The goal of this clinical trial is to investigate whether there are significant differences in the efficacy of infliximab monotherapy and combined azathioprine therapy in treating pediatric Crohn's disease, as well as whether there are differences in the safety of these two treatment regimens during long-term use. The main questions it aims to answer are:
Is infliximab combined with azathioprine superior to monotherapy in inducing and maintaining remission of Crohn's disease in children? In long-term treatment, can infliximab combined with azathioprine more effectively reduce disease activity and the occurrence of complications, but the incidence of adverse reactions is not higher than that of monotherapy? Researchers will compare the treatment of infliximab combined with azioprine with that of infliximab monotherapy to assess the efficacy and safety of both in inducing and maintaining remission of Crohn's disease in children.
Participants will:
Take drug ABC or a placebo every day for 4 months Experimental group: Infliximab, administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter, along with azathioprine, taken orally at 1.5-2.5mg/kg daily.
Control group: Infliximab (Remicade), administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter.
A comprehensive disease assessment will be conducted at the hospital in the 14th and 54th weeks.
Record their symptoms, signs and test results.

Start Date01 Mar 2026

Sponsor / Collaborator

The Children's Hospital of Zhejiang University School of Medicine

[+2]

NCT07271069

/ Not yet recruitingNot Applicable

Real-world Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis: A Chart Review Study

The purpose of this study is to evaluate the effectiveness and safety of ozanimod vs azathioprine for the treatment of ulcerative colitis (UC) in real-world clinical practice in Japan

Start Date28 Feb 2026

Sponsor / Collaborator

Bristol Myers Squibb Co.

CTRI/2026/01/100127

/ Not yet recruitingNot ApplicableIIT

Prospective randomized comparative study of graft rejection between Prolonged Release Tacrolimus and Azathioprine vs. Immediate Release Tacrolimus and Mycophenolate Mofetil in Living Donor Liver Transplant recipients - NIL

Start Date26 Jan 2026

Sponsor / Collaborator-

100 Clinical Results associated with Azathioprine

100 Translational Medicine associated with Azathioprine

100 Patents (Medical) associated with Azathioprine

20,185

Literatures (Medical) associated with Azathioprine

01 Apr 2026·Archivos Argentinos de Pediatria

Treatment-associated posterior reversible encephalopathy syndrome in an adolescent with Crohn’s disease: A case report

Article

Author: Slaifstein, Cynthia ; Díaz Pumará, Estanislao ; Salas Victoria, Micaela ; Feuerstein, Manuel

Posterior reversible encephalopathy syndrome (PRES) is a type of leukoencephalopathy that usually presents symptoms such as headache, altered consciousness, seizures, blurred vision, and imaging signs such as subcortical white matter edema, predominantly in the parieto-occipital lobes. Numerous risk factors have been identified, which involve impaired cerebral blood flow autoregulation and vasogenic edema. We present the case of a 14-year-old female patient who, in the context of an induction treatment for Crohn's disease with high-dose corticosteroids, azathioprine, and infliximab, presented with posterior reversible encephalopathy, a rare complication in patients with inflammatory bowel disease.

01 Apr 2026·DEN open

Vedolizumab Induces Remission in Two Cases of Ulcerative Colitis With Upper Gastrointestinal Involvement

Article

Author: Otoyama, Yumi ; Yoshida, Hitoshi ; Katagiri, Atsushi ; Higuchi, Kensuke ; Nakatani, Shinya ; Suzuki, Norihiro ; Ohara, Jyun ; Fujiwara, Takahisa ; Kikuchi, Kazuo ; Yamazaki, Yuta

ABSTRACT:

Ulcerative colitis (UC) predominantly affects the colon; upper gastrointestinal involvement (UGI) has been reported, but no established treatments exist. We report two cases of UC with concomitant UGI that showed positive responses to vedolizumab therapy. Case 1 involved a 29‐year‐old man who developed continuous inflammation extending from the stomach to the jejunum 1 month after an initial UC diagnosis. Intravenous prednisolone provided clinical remission; however, maintenance therapy with oral azathioprine was unsuccessful. Vedolizumab was initiated. Three months later, esophagogastroduodenoscopy (EGD) and colonoscopy confirmed the resolution of inflammation. Case 2 involved a 19‐year‐old man diagnosed with UGI via endoscopy while being evaluated for nausea and fever during UC treatment. 5‐aminosalicylic acid and prednisolone therapies were ineffective; therefore, vedolizumab was administered. Three months later, EGD confirmed mucosal healing. Both patients have maintained clinical remission for >2 years. To our knowledge, this is the first report of UC with UGI involvement that was successfully treated with vedolizumab. These findings suggest that vedolizumab is effective and safe for UGI treatment.

01 Apr 2026·Radiology case reports

Disseminated tuberculosis presenting as a refractory perianal abscess in a Crohn’s disease patient: A case report

Article

Author: Zamani, Ouijdane ; Saouab, Rachida ; Ennouali, Hassan ; Edderai, Meriem ; Farouki, Aymane El ; Bassel, Saber Abdellah ; Fenni, Jamal El

Disseminated tuberculosis (TB) is an important opportunistic infection in patients with Crohn's disease receiving immunosuppressive therapy, where its manifestations may mimic inflammatory or infectious Crohn's complications. Case: We describe a 40-year-old man with Crohn's disease on azathioprine who presented with a recurrent perianal abscess unresponsive to antibiotics. CT revealed multiple hepatic and splenic micronodules with mild rim enhancement, in addition to randomly distributed pulmonary micronodules and small nodules, raising suspicion for disseminated TB. CT-guided aspiration of the perianal collection confirmed Mycobacterium tuberculosis on GeneXpert MTB/RIF. This case emphasizes that disseminated TB should be considered in immunosuppressed Crohn's patients presenting with atypical or refractory perianal collections, and highlights key radiologic features that help differentiate TB from Crohn's-related complications.

145

News (Medical) associated with Azathioprine

27 Feb 2026

·www.prnewswire.com

Lilly's Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata

The positive opinion is based on data from the Phase 3 BRAVE-AA-PEDS study, in which 42% of patients with severe alopecia areata (AA) reached 80% or more scalp hair coverage at 36 weeks The study is the first and largest of its kind specifically designed to evaluate children and adolescents with severe AA, a disease that has devastating social and emotional impact Lilly has also submitted Olumiant in the U.S. for approval to treat severe AA in adolescents, with a decision expected in the second half of 2026 INDIANAPOLIS, Feb. 27, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Olumiant (baricitinib) for the treatment of adolescents (ages 12 to <18) with severe alopecia areata (AA). AA is a chronic immune disease that can have an especially devastating social and emotional impact on young patients and their families, as early onset AA can be more severe and lead to extensive and unpredictable hair loss.1 "The positive CHMP opinion supports the potential expansion of Olumiant as a new treatment option for adolescents living with the profound physical and emotional realities of severe alopecia areata," said Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs. "The depth and rigor of data from BRAVE-AA-PEDS – the first and largest trial designed specifically for these young patients – reflects Lilly's longstanding commitment to advancing care for people with chronic skin diseases who have had limited options for far too long." Olumiant is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. In 2022, the European Commission (EC) and U.S. Food and Drug Administration (FDA) approved Olumiant for adult patients with severe AA, making it the first JAK inhibitor approved in these geographies for severe disease. This positive opinion marks the next step toward European regulatory approval of Olumiant for adolescents ages 12 to under 18 with severe AA, and it is now referred to the European Commission for final action. The European Commission's decision is expected in the next one to two months. The positive CHMP opinion is supported by 36-week data from the Phase 3 BRAVE-AA-PEDS study evaluating the safety and efficacy of once-daily, oral Olumiant compared with placebo in the cohort of patients ages 12 to under 18. Treatment with Olumiant helped many adolescents achieve near-complete scalp hair regrowth. Additionally, many patients achieved successful eyebrow and eyelash regrowth.2 The safety profile of Olumiant in adolescents with AA was consistent with the safety profile seen in clinical trials for children with juvenile idiopathic arthritis and moderate-to-severe atopic dermatitis.2 In addition, 52-week efficacy and safety data demonstrating successful hair regrowth on the scalp, eyebrows and eyelashes in adolescent patients were also recently presented at the Fall Clinical Dermatology (FCD) Conference in October 2025. Olumiant is the most-researched JAK inhibitor in AA. In total for all indications, more than 14,600 patients have received Olumiant in completed and ongoing clinical trials. Of these, over 1,200 have been children and adolescents. "Adolescents with severe alopecia areata represent a particularly vulnerable population, as the disease is difficult to manage and occurs at a time when appearance can have a significant impact on social identity and emotional well-being," said Thierry Passeron, M.D., PhD, professor and chair, Department of Dermatology, Université Côte d'Azur. "In clinical practice, families are frequently left with limited options that fall short. If approved in the European Union, Olumiant will represent an important evidence-based treatment option for these young patients — and with it, the hope that more adolescents living with severe alopecia areata can be helped." Lilly has submitted Olumiant in the U.S. for approval to treat severe AA in adolescents, with a decision expected in the second half of 2026. About BRAVE-AA-PEDS BRAVE-AA-PEDS (NCT05723198) is an ongoing, placebo-controlled, Phase 3 clinical trial involving children and adolescents ages 6 to under 18 years with severe AA, as measured by a SALT score of ≥50 (i.e., who had ≥ 50% scalp hair loss) and a current episode of severe AA lasting at least six months but no more than eight years. The first two cohorts of patients enrolled in BRAVE-AA-PEDS included adolescents (ages 12 to under 18 years, weighing ≥ 30 kg). The first cohort included 257 adolescent participants who were randomized in a 1:1:1 ratio to receive once-daily placebo, Olumiant 4 mg or Olumiant 2 mg. The primary endpoint of this study was a SALT score ≤20 (i.e., 80% or more scalp hair coverage) at Week 36. The second cohort of 166 adolescents were randomized 1:1 to Olumiant 4 mg or Olumiant 2 mg to further accumulate safety data. The third cohort consists of children ages 6 to under 12 years and will be randomized in a 1:1:1 ratio to receive once-daily placebo, Olumiant high dose or Olumiant low dose.3 About Olumiant Olumiant, a once-daily, oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. Baricitinib is approved in the U.S. and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis, in more than 40 countries outside the U.S. for the treatment of patients down to the age of two with moderate-to-severe atopic dermatitis who are candidates for systemic therapy and in the U.S., Europe and Japan for adult patients with severe AA. Marketing authorization for the treatment of hospitalized patients with COVID-19 has been granted for baricitinib in multiple countries. The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis. See the full Prescribing Information here.4 In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of Olumiant and certain follow-on compounds for patients with inflammatory and autoimmune diseases. INDICATIONS AND SAFETY SUMMARY WITH WARNINGS (in the United States) Olumiant ® (O-loo-mē-ant) is a Janus kinase (JAK) inhibitor used to treat: adults with severe alopecia areata. adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated. Warnings - Olumiant may cause serious side effects, including: Serious infections, including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as: fever, sweating, or chills muscle aches cough shortness of breath blood in phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning with urination or urinating more often than normal feeling tired If you get a serious infection, your doctor may stop Olumiant until your infection is controlled. Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors. Cancer and immune system problems. Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor's advice about having your skin checked for skin cancer while taking Olumiant. Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded weakness in one part or on one side of your body slurred speech Blood clots in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant. Allergic reactions. While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious. Tears in the stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits. Changes in laboratory test results. Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed. Common side effects The most common side effects of Olumiant in people treated for alopecia areata include: upper respiratory tract infections (cold or sinus infections) headache acne increased cholesterol levels increased muscle enzyme levels urinary tract infection increased liver enzyme levels inflammation of hair follicles (folliculitis) tiredness lower respiratory tract infections nausea genital yeast infection low red blood cell count (anemia) low white blood cell count (neutropenia) stomach-area (abdominal) pain shingles (herpes zoster) increased weight The most common side effects of Olumiant in people treated for rheumatoid arthritis include: upper respiratory tract infections (cold or sinus infections) nausea herpes simplex virus infections, including cold sores shingles (herpes zoster) These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects. You can report side effects to the FDA at 1-800-FDA-1088 or . Before using Before you use Olumiant, tell your doctor if you: ❑ Are being treated for an infection, have an infection that won't go away or keeps coming back, or think you have symptoms of an infection. ❑ Have TB or have been in close contact with someone with TB. ❑ Have had shingles (herpes zoster). ❑ Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs. ❑ Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common. ❑ Are a current or past smoker. ❑ Have had a heart attack, other heart problems or stroke. ❑ Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system. ❑ Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines. ❑ Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines. ❑ Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1‑800‑545-5979 to report the pregnancy. ❑ Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant. ❑ Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take: a medicine called probenecid medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection. ❑ Are under age 18. It is not known if Olumiant is safe and effective in children. How to take Take Olumiant exactly as your doctor says. Take Olumiant once a day by mouth with or without food. Talk to your doctor if you cannot swallow tablets whole. If you take too much Olumiant, call your doctor or poison control center at 1‑800‑222‑1222, or go to the nearest hospital emergency room right away. Learn more Olumiant is a prescription medicine. For more information, call 1-800-545-5979 or go to . This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you. BA CON BS 14SEP2022 About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Olumiant (baricitinib) as a treatment for alopecia areata and reflects Lilly's and Incyte's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, and that Olumiant will receive additional regulatory approvals, or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release. References Toussi, A., Barton, V. R., Le, S. T., Agbai, O. N., & Kiuru, M. (2021). Psychosocial and psychiatric comorbidities and health-related quality of life in alopecia areata: A systematic review. Journal of the American Academy of Dermatology, 85(1), 162–175. Passeron T, et al. Baricitinib provides significant hair regrowth in adolescents with severe alopecia areata: 36-week efficacy and safety results from a Phase 3 randomized, controlled trial. American Academy of Dermatology Annual Meeting. March 7-11, 2025. Craiglow B, et al. Baricitinib provides significant hair regrowth in adolescents with severe alopecia areata: 52-week efficacy and safety results from a Phase 3 randomized, controlled trial. 2025 Fall Clinical Dermatology Conference. October 24, 2025. Olumiant. Prescribing Information. Lilly USA, LLC. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo

Phase 3Clinical ResultDrug ApprovalLicense out/in

26 Nov 2025

·www.prnewswire.com

Celltrion announces publication of post-hoc analysis of LIBERTY-CD study of ZYMFENTRA® (infliximab-dyyb), indicating consistent efficacy across disease location, including the terminal ileum in Clinical Gastroenterology and Hepatology journal

Findings from the post-hoc analysis of LIBERTY-CD study indicates efficacy of ZYMFENTRA® (subcutaneous infliximab) regardless of disease location, consistent across ileum-dominant and colon-dominant Crohn's disease (CD) Findings support the therapeutic potential of ZYMFENTRA in addressing persistent treatment gaps especially in ileum-dominant CD INCHEON, South Korea, Nov. 26, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that a post-hoc analysis of the LIBERTY-CD study, which showed that the efficacy of ZYMFENTRA® (infliximab-dyyb) is consistent regardless of disease location, has been published in a peer reviewed journal, Clinical Gastroenterology and Hepatology.[1] "The consistency of treatment effect across disease locations is important, as ileal Crohn's disease (CD) is highly correlated with negative long-term outcomes and the fact that the terminal ileum being the most challenging segment to treat," said Prof. Jean-Frédéric Colombel, MD, Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. "The consistent clinical and endoscopic outcomes observed with subcutaneous formulation of infliximab, regardless of disease location, suggest its potential as an effective therapy across different ileocolonic segments." The post hoc analysis utilized the endoscopic data from the phase 3 LIBERTY-CD trial of subcutaneous formulation of infliximab (infliximab SC), ZYMFENTRA, to investigate the clinical outcomes and related predictive factors by disease location in patients with moderately-to-severely active CD who received infliximab SC maintenance treatment. Among 329 patients, 52.6% had colon-dominant CD (n=173) and 47.4% had ileum-dominant CD (n=105). At Week 54, patients receiving infliximab SC achieved significantly greater efficacy outcomes across all endpoints compared with placebo, regardless of disease location. Rates of clinical remission were 60.95% in the ileum-dominant group and 66.95% in the colon-dominant group, versus 37.25% and 29.09%, respectively, in the placebo group. Clinical response and endoscopic response rates similarly favored infliximab SC over placebo in both location groups (clinical response: 62.86% vs 41.18% in ileum-dominant and 67.80% vs 38.18% in colon-dominant; endoscopic response: 53.33% vs 19.61% in ileum-dominant and 52.54% vs 18.18% in colon dominant). When assessed at the segment level, endoscopic responses at Week 54 were greater with infliximab SC versus placebo across all ileocolonic segments, including the terminal ileum, with consistent treatment effect sizes observed throughout each segment. "As 70-80% of patients with Crohn's disease have ileal involvement at diagnosis, effective treatment of the ileum has the potential to benefit a large proportion of patients with Crohn's disease," said Nam Lee, Vice President of Global Medical Affairs at Celltrion. "It is encouraging to have this additional analysis that supports consistent efficacy of subcutaneous infliximab regardless of different disease location and segments." The full manuscript "Endoscopic response to subcutaneous infliximab by disease location: A post hoc analysis of the LIBERTY-CD study" is available online at Clinical Gastroenterology and Hepatology today. Notes to Editors: About ZYMFENTRA® (infliximab-dyyb; subcutaneous infliximab) ZYMFENTRA® (infliximab-dyyb) is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately-to-severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), Moderately-to-severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body. ZYMFENTRA was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040. Indication and Important Safety Information ZYMFENTRA® is a prescription medicine indicated in adults for maintenance treatment of: Moderately-to-severely active Crohn's disease following treatment with an infliximab product administered intravenously. Moderately-to-severely active ulcerative colitis following treatment with an infliximab product administered intravenously. It is not known if ZYMFENTRA is safe and effective in children under 18 years of age. What is the most important information I should know about ZYMFENTRA? SERIOUS INFECTIONS Patients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection. MALIGNANCIES Malignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants. Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis, and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with ZYMFENTRA, especially in these patient types. In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. CONTRAINDICATIONS ZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension and serum sickness). HEPATITIS B VIRUS REACTIVATION TNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of ZYMFENTRA and monitor patients closely. HEPATOTOXICITY Hepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia and non-alcoholic fatty liver, have been reported in patients receiving infliximab products post-marketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued and a thorough investigation of the abnormality should be undertaken. CONGESTIVE HEART FAILURE Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF. HEMATOLOGIC REACTION Cases of leukopenia, neutropenia, thrombocytopenia and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of ZYMFENTRA in patients who develop significant hematologic abnormalities. HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONS In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylaxis, hypotension and serum sickness) have been reported following administration of infliximab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. INJECTION SITE REACTIONS In clinical studies, localized injection-site reactions were reported following administration of ZYMFENTRA. If a clinically significant injection-site reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. NEUROLOGIC REACTIONS Agents that inhibit TNF have been associated with central nervous system (CNS) manifestation of systemic vasculitis, seizure and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop. RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTS Serious infections and neutropenia have been reported with concurrent use of ZYMFENTRA with other immunosuppressive biological products. The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended. RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTS Consider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA. AUTOIMMUNITY Treatment with TNF blockers may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of a lupus-like syndrome develop. VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS Prior to initiating ZYMFENTRA, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA due to the possibility of clinical infections, including disseminated infections. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to ZYMFENTRA. ADVERSE REACTIONS In clinical trials with ZYMFENTRA, the most common adverse reactions occurring in ≥3% of ZYMFENTRA-treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase and abdominal pain for UC, and COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD. Please click for Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About Celltrion , Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website . and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), OMLYCLO® (omalizumab-igec), and EYDENZELT® (aflibercept-boav) as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipate" the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. For further information please contact: Katie Gallagher [email protected] +1 617-657-1324 SOURCE Celltrion 21% more press release views with Request a Demo

Clinical ResultDrug ApprovalPhase 3Vaccine

26 Nov 2025

·www.celltrion.com

Findings from the post-hoc analysis of LIBERTY-CD study indicates efficacy of ZYMFENTRA® (subcutaneous infliximab) regardless of disease location, consistent across ileum-dominant and colon-dominant Crohn's disease (CD) Findings support the therapeutic potential of ZYMFENTRA in addressing persistent treatment gaps especially in ileum-dominant CD INCHEON, South Korea, Nov. 26, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that a post-hoc analysis of the LIBERTY-CD study, which showed that the efficacy of ZYMFENTRA® (infliximab-dyyb) is consistent regardless of disease location, has been published in a peer reviewed journal, Clinical Gastroenterology and Hepatology.[1] "The consistency of treatment effect across disease locations is important, as ileal Crohn's disease (CD) is highly correlated with negative long-term outcomes and the fact that the terminal ileum being the most challenging segment to treat," said Prof. Jean-Frédéric Colombel, MD, Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. "The consistent clinical and endoscopic outcomes observed with subcutaneous formulation of infliximab, regardless of disease location, suggest its potential as an effective therapy across different ileocolonic segments." The post hoc analysis utilized the endoscopic data from the phase 3 LIBERTY-CD trial of subcutaneous formulation of infliximab (infliximab SC), ZYMFENTRA, to investigate the clinical outcomes and related predictive factors by disease location in patients with moderately-to-severely active CD who received infliximab SC maintenance treatment. Among 329 patients, 52.6% had colon-dominant CD (n=173) and 47.4% had ileum-dominant CD (n=105). At Week 54, patients receiving infliximab SC achieved significantly greater efficacy outcomes across all endpoints compared with placebo, regardless of disease location. Rates of clinical remission were 60.95% in the ileum-dominant group and 66.95% in the colon-dominant group, versus 37.25% and 29.09%, respectively, in the placebo group. Clinical response and endoscopic response rates similarly favored infliximab SC over placebo in both location groups (clinical response: 62.86% vs 41.18% in ileum-dominant and 67.80% vs 38.18% in colon-dominant; endoscopic response: 53.33% vs 19.61% in ileum-dominant and 52.54% vs 18.18% in colon dominant). When assessed at the segment level, endoscopic responses at Week 54 were greater with infliximab SC versus placebo across all ileocolonic segments, including the terminal ileum, with consistent treatment effect sizes observed throughout each segment. "As 70-80% of patients with Crohn's disease have ileal involvement at diagnosis, effective treatment of the ileum has the potential to benefit a large proportion of patients with Crohn's disease," said Nam Lee, Vice President of Global Medical Affairs at Celltrion. "It is encouraging to have this additional analysis that supports consistent efficacy of subcutaneous infliximab regardless of different disease location and segments." The full manuscript "Endoscopic response to subcutaneous infliximab by disease location: A post hoc analysis of the LIBERTY-CD study" is available online at Clinical Gastroenterology and Hepatology today. Notes to Editors: About ZYMFENTRA® (infliximab-dyyb; subcutaneous infliximab) ZYMFENTRA® (infliximab-dyyb) is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately-to-severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), Moderately-to-severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body. ZYMFENTRA was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040. Indication and Important Safety Information ZYMFENTRA® is a prescription medicine indicated in adults for maintenance treatment of: Moderately-to-severely active Crohn's disease following treatment with an infliximab product administered intravenously. Moderately-to-severely active ulcerative colitis following treatment with an infliximab product administered intravenously. It is not known if ZYMFENTRA is safe and effective in children under 18 years of age. What is the most important information I should know about ZYMFENTRA? SERIOUS INFECTIONS Patients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection. MALIGNANCIES Malignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants. Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis, and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with ZYMFENTRA, especially in these patient types. In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. CONTRAINDICATIONS ZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension and serum sickness). HEPATITIS B VIRUS REACTIVATION TNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of ZYMFENTRA and monitor patients closely. HEPATOTOXICITY Hepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia and non-alcoholic fatty liver, have been reported in patients receiving infliximab products post-marketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued and a thorough investigation of the abnormality should be undertaken. CONGESTIVE HEART FAILURE Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF. HEMATOLOGIC REACTION Cases of leukopenia, neutropenia, thrombocytopenia and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of ZYMFENTRA in patients who develop significant hematologic abnormalities. HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONS In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylaxis, hypotension and serum sickness) have been reported following administration of infliximab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. INJECTION SITE REACTIONS In clinical studies, localized injection-site reactions were reported following administration of ZYMFENTRA. If a clinically significant injection-site reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. NEUROLOGIC REACTIONS Agents that inhibit TNF have been associated with central nervous system (CNS) manifestation of systemic vasculitis, seizure and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop. RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTS Serious infections and neutropenia have been reported with concurrent use of ZYMFENTRA with other immunosuppressive biological products. The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended. RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTS Consider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA. AUTOIMMUNITY Treatment with TNF blockers may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of a lupus-like syndrome develop. VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS Prior to initiating ZYMFENTRA, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA due to the possibility of clinical infections, including disseminated infections. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to ZYMFENTRA. ADVERSE REACTIONS In clinical trials with ZYMFENTRA, the most common adverse reactions occurring in ≥3% of ZYMFENTRA-treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase and abdominal pain for UC, and COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD. Please click for Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website https://www.celltrion.com/en-us. and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), OMLYCLO® (omalizumab-igec), and EYDENZELT® (aflibercept-boav) as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipate" the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. References [1] Bruce E. Sands et al., Endoscopic response to subcutaneous infliximab by disease location: A post hoc analysis of the LIBERTY-CD study. Clinical Gastroenterology and Hepatology. 2025.

Clinical ResultDrug ApprovalPhase 3Vaccine

100 Deals associated with Azathioprine

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KEGG	Wiki	ATC	Drug Bank
D00238	Azathioprine	L04AX01	DB00993

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10 top approved records.

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Indication	Country/Location	Organization	Date
Behcet Syndrome	European Union	Lipomed AG	21 Jun 2021
Behcet Syndrome	Iceland	Lipomed AG	21 Jun 2021
Behcet Syndrome	Liechtenstein	Lipomed AG	21 Jun 2021
Behcet Syndrome	Norway	Lipomed AG	21 Jun 2021
Chronic idiopathic thrombocytopenic purpura	European Union	Lipomed AG	21 Jun 2021
Chronic idiopathic thrombocytopenic purpura	Iceland	Lipomed AG	21 Jun 2021
Chronic idiopathic thrombocytopenic purpura	Liechtenstein	Lipomed AG	21 Jun 2021
Chronic idiopathic thrombocytopenic purpura	Norway	Lipomed AG	21 Jun 2021
Inflammatory Bowel Diseases	European Union	Lipomed AG	21 Jun 2021
Inflammatory Bowel Diseases	Iceland	Lipomed AG	21 Jun 2021
Inflammatory Bowel Diseases	Liechtenstein	Lipomed AG	21 Jun 2021
Inflammatory Bowel Diseases	Norway	Lipomed AG	21 Jun 2021
Multiple sclerosis relapse	European Union	Lipomed AG	21 Jun 2021
Multiple sclerosis relapse	Iceland	Lipomed AG	21 Jun 2021
Multiple sclerosis relapse	Liechtenstein	Lipomed AG	21 Jun 2021
Multiple sclerosis relapse	Norway	Lipomed AG	21 Jun 2021
Myasthenia Gravis	European Union	Lipomed AG	21 Jun 2021
Myasthenia Gravis	Iceland	Lipomed AG	21 Jun 2021
Myasthenia Gravis	Liechtenstein	Lipomed AG	21 Jun 2021
Myasthenia Gravis	Norway	Lipomed AG	21 Jun 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2025	Not Applicable	Purpura, Thrombocytopenic, Idiopathic First line	103	Dexamethasone and Eltrombopag (DE)	fxwfxifizu(vkxvgenxii) = rhprcmiopp jxtzvkfaah (zvbwbdvdli ) View more	Positive	06 Dec 2025
				Dexamethasone, Eltrombopag and Azathioprine (DEA)	fxwfxifizu(vkxvgenxii) = cdkosooisx jxtzvkfaah (zvbwbdvdli ) View more
ACR2025	Not Applicable	Systemic Lupus Erythematosus	150	Azathioprine	puvluuelsx(yettrcfubf) = ktssbntjhz uhzjmeqpcb (xoqqhkjkjo ) View more	Positive	24 Oct 2025
ACR2025	Not Applicable	Lupus Nephritis	2,052	Mycophenolate mofetil (MMF)	cvcqiwuewh(fboxznqjhq) = dcqkttjvjx xonxchokuq (lozbwdwqpw )	Positive	24 Oct 2025
				Azathioprine (AZA)	cvcqiwuewh(fboxznqjhq) = msqaugcsvf xonxchokuq (lozbwdwqpw )
EURETINA2025	Not Applicable	Uveomeningoencephalitic Syndrome	8	High-dose intravenous methylprednisolone followed by oral corticosteroids and steroid-sparing immunosuppressants (mycophenolate mofetil, azathioprine, or cyclosporine). In refractory cases, biologic therapy (adalimumab)	buojskdjnl(ljbizkbidb) = One patient, initially treated elsewhere, had a flare due to non-adherence to adalimumab msqgkeccps (mzfreblwix ) View more	Positive	04 Sep 2025
NCT06476366 (CTgov)	Early Phase 1	Dermatitis	20	Methotrexate (Methotrexate Arm)	rwdbilmvjw = twccqlkmvt jyntshyunl (pefqbjayza, ormejixxac - mzxkjemgxm) View more	-	17 Aug 2025
				Azathioprine (Azathioprine)	rwdbilmvjw = jmpkzlxvvo jyntshyunl (pefqbjayza, fcsdufyjnb - hlweqeeazt) View more
AAD2025	Not Applicable	Lichen Planus, Oral	125	Mycophenolate	elmmnkmkck(hudxtnbteb) = In the overall cohort, male sex was associated with a 2.3-fold increased risk of discontinuation for adverse events (95% confidence interval=1.2-4.2). jimikpzkez (wyowpeptzy )	Negative	07 Mar 2025
NCT00984568 \| NCT03580876 \| NCT03101800 \| NCT02910245 \| NCT02929706 \| NCT00537316 \| NCT03370601 \| NCT04304950 \| NCT03151525 \| NCT00542152 \| NCT02579733 (Pubmed \| Cochrane Database Syst Rev)	Not Applicable	Colitis, Ulcerative Maintenance	468	Azathioprine	hqgqyvhajm(jypfuswcae) = zygqommwix vqxqzzuyrp (imsqwiclia, 0.54 - 0.82)	Positive	27 Feb 2025
				6-mercaptopurine	xbjvzpkudk(qaizfjenzp) = kncxbpaqyl cefuuboubs (nswfeijvee, 0.13 - 0.97)
ACR2024	Not Applicable	Takayasu Arteritis	111	Mycophenolate Mofetil + Methotrexate	wdyvjkxldn(kwaaaxawwk) = daaiwptkwp tzcaypcdlf (tvzoxjkfmf ) View more	Positive	10 Nov 2024
				Cyclophosphamide followed by Azathioprine	wdyvjkxldn(kwaaaxawwk) = rkmfoxhhdp tzcaypcdlf (tvzoxjkfmf ) View more
EULAR2024	Not Applicable	Lupus Nephritis	-	Azathioprine	kxcvptruul(gijpaxjsos) = awycnzjvjh utngwypllq (cnuanhirnv )	-	05 Jun 2024
EHA2024	Not Applicable	Anemia, Sickle Cell	20	Azathioprine/Hydroxyurea Preconditioning + Alemtuzumab/TBI Conditioning	bfptashzqx(oxkenfproh) = One patient developed steroid-responsive grade II intestinal acute graft-versus-host disease pmzegurenh (ivocazpvmi ) View more	Positive	14 May 2024

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