A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects

A single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate the effect of multiple doses of Fluconazole, a CYP3A4 and CYP2C9 inhibitor, on the pharmacokinetics (PK) of CTP-543 in healthy subjects

Start Date11 Jul 2022

Sponsor / Collaborator

Concert Pharmaceuticals, Inc.

NCT05467709 / CompletedPhase 1

A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects

This is a single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to determine the effect of CTP-543 on the pharmacokinetics (PK) of midazolam in healthy adult subjects

Start Date21 Jun 2022

Sponsor / Collaborator

Concert Pharmaceuticals, Inc.

NCT05467696 / CompletedPhase 1

A Phase 1 Open-Label, Two-Period, Two-Treatment, Crossover Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers

This is an open-label, single-dose, two period crossover study to evaluate the effect of food on the bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers

Start Date14 Jun 2022

Sponsor / Collaborator

Concert Pharmaceuticals, Inc.

100 Clinical Results associated with Deuruxolitinib Phosphate

100 Translational Medicine associated with Deuruxolitinib Phosphate

100 Patents (Medical) associated with Deuruxolitinib Phosphate

Literatures (Medical) associated with Deuruxolitinib Phosphate

01 Jul 2024·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Efficacy and safety of deuruxolitinib, an oral selective Janus kinase inhibitor, in adults with alopecia areata: Results from the Phase 3 randomized, controlled trial (THRIVE-AA1)

Article

Author: Brzewski, Pawel ; Zirwas, Matthew ; Lynde, Charles ; Prajapati, Vimal H ; Wiseman, Marni C ; Maari, Catherine ; King, Brett ; Mesinkovska, Natasha A ; Sapra, Sheetal ; Hanna, Sameh ; Osman, Lawrence ; Cassella, James ; Hamilton, Colleen ; Senna, Maryanne M

BACKGROUND:

Alopecia areata (AA) is a hair loss disorder that can seriously impact quality of life. Janus kinase (JAK) inhibitors, including deuruxolitinib, have previously demonstrated significant hair regrowth in AA.

OBJECTIVE:

The Phase 3 THRIVE-AA1 randomized, double-blinded, placebo-controlled trial (NCT04518995) evaluated the safety and efficacy of the oral JAK1/JAK2 inhibitor deuruxolitinib in adult patients with AA.

METHODS:

Patients aged 18-65 years with ≥50% hair loss were randomized to deuruxolitinib 8 mg twice daily, deuruxolitinib 12 mg twice daily, or placebo for 24 weeks. The primary end point was the percentage of patients achieving a Severity of Alopecia Tool score ≤20. A key secondary end point was the percentage of satisfaction of hair patient-reported outcome responders.

RESULTS:

Significantly higher proportions of patients taking deuruxolitinib met the primary end point (8 mg 29.6%; 12 mg 41.5% versus placebo 0.8%). Both deuruxolitinib doses achieved significant improvements in all secondary end points versus placebo, including satisfaction of hair patient-reported outcome (8 mg 42.1%; 12 mg 53.0% versus placebo 4.7%). Most treatment-emergent adverse events were mild or moderate, consistent with other oral JAK inhibitors.

LIMITATIONS:

Further studies are required to understand longer-term safety, efficacy, and impact of treatment cessation.

CONCLUSION:

Both doses of deuruxolitinib were effective for hair regrowth. Patient satisfaction aligned with hair growth.

03 May 2024·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Novel investigational drugs for alopecia areata and future perspectives

Review

Author: Ghiya, Ragini ; Eisman, Samantha ; Chim, Ivana ; Sinclair, Rodney D

INTRODUCTION:

Alopecia areata (AA) is an immune-mediated disease that causes non-scarring hair loss. While acute, solitary patches often spontaneously remit, developing secondary patches or failure of the disease to resolve within 6-12 months predicts a poor prognosis, with an increased risk of alopecia totalis or universalis. Chronic AA increases the risk of depression and suicidality and reduces quality of life. Treatment options for chronic or acute diffuse AA were previously limited to corticosteroids and traditional immunomodulators. Two Janus Kinase (JAK) inhibitors are now approved for the treatment of chronic AA.

AREAS COVERED:

The results of landmark phase 3 trials for three JAK inhibitors, baricitinib, ritlecitinib, and deuruxolitinib are discussed. Evidence for other JAK inhibitors, biologics, and phosphodiesterase-4 inhibitors are also presented. Therapies currently undergoing clinical trials are listed.

EXPERT OPINION:

JAK inhibitors are a safe and efficacious treatment of moderate-to-severe AA. Early intervention, regardless of severity, allows for improved treatment efficacy. It is uncertain how long patients should remain on JAK inhibitors; discontinuation often leads to relapse. A black-box warning for JAK inhibitors was extrapolated from safety data in a rheumatoid arthritis cohort; recent meta-analyses of JAK inhibitors used in dermatology cohorts do not demonstrate the same risk profile.

01 Dec 2023·JAMA dermatology

Janus Kinase Inhibitors and Adverse Events of Acne

Review

Author: Manjaly, Priya ; Martinez, Jeremy ; Barbieri, John ; Zhou, Guohai ; Ly, Sophia ; Mostaghimi, Arash ; Manjaly, Cyriac

Importance:

Janus kinase (JAK) inhibitors are increasingly used across a range of dermatologic conditions. Adverse events of acne have been noted in some studies in clinical practice, but the scope of this outcome across JAK inhibitors has not been established.

Objective:

To systematically analyze all published phase 2 and 3 placebo-controlled randomized clinical trials (RCTs) of JAK inhibitors for the risk of acne as an adverse effect of these medications.

Data Sources:

Comprehensive search of Ovid MEDLINE and PubMed databases through January 31, 2023.

Study Selection:

Inclusion criteria were phase 2 and 3 placebo-controlled RCTs of JAK inhibitors published in English with reported adverse events of acne.

Data Extraction and Synthesis:

Two reviewers independently reviewed and extracted information from all included studies.

Main Outcomes and Measures:

The primary outcome of interest was the incidence of acne following JAK inhibitor use. A meta-analysis was conducted using random-effects models.

Results:

A total of 25 unique studies (10 839 unique participants; 54% male and 46% female) were included in the final analysis. The pooled odds ratio (OR) was calculated to be 3.83 (95% CI, 2.76-5.32) with increased ORs for abrocitinib (13.47 [95% CI, 3.25-55.91]), baricitinib (4.96 [95% CI, 2.52-9.78]), upadacitinib (4.79 [95% CI, 3.61-6.37]), deucravacitinib (2.64 [95% CI, 1.44-4.86]), and deuruxolitinib (3.30 [95% CI, 1.22-8.93]). Estimated ORs were higher across studies investigating the use of JAK inhibitors for the management of dermatologic compared with nondermatologic conditions (4.67 [95% CI, 3.10-7.05]) as well as for JAK1-specific inhibitors (4.69 [95% CI, 3.56-6.18]), combined JAK1 and JAK2 inhibitors (3.43 [95% CI, 2.14-5.49]), and tyrosine kinase 2 inhibitors (2.64 [95% CI, 1.44-4.86]).

Conclusions and Relevance:

In this systematic review and meta-analysis, JAK inhibitor use was associated with an elevated odds of acne. Patients should be properly counseled on this potential adverse effect of these medications before treatment initiation. Future studies are needed to further elucidate the pathophysiology of this association.

News (Medical) associated with Deuruxolitinib Phosphate

26 Sep 2024

·www.prnewswire.com

Sun Pharma Presents New Clinical Efficacy and Safety Data in Severe Dermatological Conditions at the 2024 European Academy of Dermatology and Venereology (EADV) Congress

New data demonstrate improved hair satisfaction in more than 95% of patients taking deuruxolitinib and clinically meaningful improvements in depression and anxiety from baseline to Week 24 Studies also confirm dose optimization, with results demonstrating greater response with 8 mg tablets twice-daily as compared to higher once-daily dosing MUMBAI, India and PRINCETON, N.J., Sept. 26, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or affiliated companies, "Sun Pharma") today announced that it will present abstracts across its dermatology portfolio at the 33rd European Academy of Dermatology and Venereology (EADV) Congress being held in Amsterdam, Netherlands from September 25-28, 2024. Three abstracts, accepted for podium and poster presentation, will highlight clinical efficacy and safety data of LEQSELVI™ (deuruxolitinib) 8 mg tablets, an oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2 approved by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata (AA). Notably, data presented in the podium presentation (FC04.04) found a greater proportion (95%) of patients taking deuruxolitinib 8 mg twice a day showed improvement in their hair satisfaction scores, compared to baseline over the 24-week period. Satisfaction with hair regrowth is imperative, as a significant number of patients with AA experience depression and anxiety due to the visible nature of the disease.1 The company will also share results in two additional posters for deuruxolitinib, which showed clinically meaningful improvement in anxiety and depression among patients taking deuruxolitinib to treat their severe AA (P2022) as well as dose optimization for deuruxolitinib at 8 mg (P2081). "Deuruxolitinib targets the immune mechanisms behind alopecia areata, providing patients with an effective treatment option," said Arash Mostaghimi, MD, MPA, MPH, FAAD, Vice Chair, Clinical Trials and Innovation and Director, Inpatient Dermatology, Brigham and Women's Hospital. "As a dermatologist, I find these data particularly encouraging because it addresses the physical effects of hair loss, which can, in turn, address the significant emotional and mental health challenges that patients often face." Additionally, 12 poster presentations will underscore the clinical efficacy and safety of ILUMYA® (tildrakizumab) in moderate-to-severe plaque psoriasis. These data also include research from interim data analysis from real-world settings. The following abstracts representing the dermatology portfolio will be presented at the 33rd EADV Congress: Deuruxolitinib Podium Presentation [FC04.04]: Change in patient-reported hair satisfaction during deuruxolitinib treatment of severe alopecia areata: Pooled data from the Phase 3 THRIVE-AA1 and THRIVE-AA2 trials (Presentation Time: September 26 at 16:30-16:40) Poster Presentation [P2022]: Improvement in anxiety and depression in adult patients with severe alopecia areata treated with deuruxolitinib: Pooled data from the THRIVE-AA1 and THRIVE-AA2 Phase 3 trials Poster Presentation [P2081]: Optimization of deuruxolitinib dosing in adult patients with alopecia areata: Results from a randomized, parallel-group, multicenter, Phase 2 trial Tildrakizumab Poster Presentation [P3221]: Comparative Efficacy and Safety of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis: Systematic Literature Review (SLR) and Network Meta-Analysis (NMA) Poster Presentation [P3177]: Efficacy and safety of tildrakizumab through Week 28 in patients with early vs late-onset moderate-to-severe plaque psoriasis: A post hoc analysis of reSURFACE 1 and reSURFACE 2 Poster Presentation [P3274]: Improving the well-being of patients with moderate to severe plaque psoriasis and involvement of impactful areas with Tildrakizumab* Poster Presentation [P3348]: Effectiveness and Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) of tildrakizumab patients with nail psoriasis: 52-week results from the phase IV POSITIVE Austrian subset* Poster Presentation [P3343]: Effectiveness of tildrakizumab in patients with moderate-to-severe psoriasis located in special areas: 52-week results from the POSITIVE study* Poster Presentation [P3341]: High effectiveness of tildrakizumab in bio-naïve and bio-experienced patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study* Poster Presentation [P3340]: High effectiveness of tildrakizumab regardless of baseline characteristics in patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study* Poster Presentation [P3188]: Patient-reported well-being using tildrakizumab for psoriasis in a real-world setting: 52-week interim data of the phase IV POSITIVE study* Poster Presentation [P3339]: Safety of tildrakizumab in patients with moderate-to-severe psoriasis: 52-week data from the phase IV POSITIVE study* Poster Presentation [P3346]: Effectiveness of tildrakizumab for itch, pain, and fatigue in patients with moderate-to-severe psoriasis: 52-week results from the real-world POSITIVE study* Poster Presentation [P3347]: Quality of life, work productivity and treatment satisfaction with tildrakizumab in moderate-to-severe psoriasis patients: 52-week interim data of the real-world POSITIVE study* Poster Presentation [P3344]: (ENCORE) Impact of patient psoriasis on partner well-being in a real-world setting: 52- week interim data of the phase IV POSITIVE study* * Indicates data sponsored by Almirall; Sun Pharma and Almirall operate under a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe About LEQSELVI™ and alopecia areata LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 approved for the treatment of adult patients with severe alopecia areata. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime.2,3,4 The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata. About THRIVE-AA1 and THRIVE-AA2 trial design THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650) were randomized, double-blind, placebo-controlled clinical trials in 1223 adult patients ages 18-65 with severe alopecia areata at sites in the U.S., Canada and Europe evaluating the regrowth of scalp hair after 24 weeks of dosing using the Severity of Alopecia Tool (SALT) score. Patients were randomized to receive either 8 mg twice daily or 12 mg twice daily of deuruxolitinib or placebo for 24 weeks. The primary endpoint was the percentage of patients achieving a SALT score of 20 or less at 24 weeks. Patients enrolled in THRIVE-AA1 and THRIVE-AA2 were required to have at least 50 percent scalp hair loss due to alopecia areata, as measured by SALT. A SALT score of 100 represents total scalp hair loss, whereas a score of 0 represents no scalp hair loss. The average baseline SALT score across all patients in THRIVE-AA1 and THRIVE-AA2 was approximately 85.9 and 87.9 respectively. LEQSELVI Important Safety Information Please click here for full Prescribing Information Including BOXED WARNING and Medication Guide. Indications and Usage LEQSELVI (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. Contraindications LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors. Warnings Serious Infections Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB) that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. Mortality Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. Malignancy Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. Major Adverse Cardiovascular Events Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. Thrombosis Thrombosis, including PE, DVT & CVT, has occurred in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. Increased risk of serious adverse reactions in CYP2C9 poor metabolizers or with concomitant use of moderate or strong CYP2C9 inhibitors Do not treat patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor with LEQSELVI. Gastrointestinal Perforations GI perforations have occurred in patients treated with LEQSELVI. Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms. Lipid elevations, anemia, neutropenia, and lymphopenia Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. Immunizations Avoid use of live vaccines during or immediately prior to LEQSELVI treatment. Prior to initiating LEQSELVI, it is recommended that patients be brought up to date with all immunizations. Dosage The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food. Before treatment with LEQSELVI, perform the following evaluations: CYP2C9 genotype & use of moderate or strong CYP2C9 inhibitors; Active and latent tuberculosis evaluation; Viral hepatitis screening; Complete blood count (LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm3 absolute neutrophil count (ANC) <1,000 cells/mm3, or hemoglobin level <8 g/dl). Adverse Reactions Most common adverse reactions (≥1%) are headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes. Use in Specific Populations Based on animal studies, LEQSELVI may cause fetal harm during pregnancy. Pregnant women should be advised of a risk to the fetus. Consider pregnancy planning and prevention for women of reproductive potential. LEQSELVI should not be used by women who are breastfeeding until one day after the last dose. LEQSELVI should not be used by patients with severe renal impairment or severe hepatic impairment. ILUMYA Important Safety Information Please click here for Full Prescribing Information and Medication Guide. INDICATION ILUMYA (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. CONTRAINDICATIONS ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients. WARNINGS AND PRECAUTIONS: Hypersensitivity: Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy. Infections: ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA until the infection resolves. Pretreatment Evaluation for Tuberculosis: Evaluate patients for tuberculosis (TB ) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after treatment. Immunizations: Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines. Adverse Reactions: The most common (≥1 % ) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or . Disclaimer Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. References Cleveland Clinic. Alopecia Areata. . Benigno M. A Large Cross-Sectional Survey Study of the Prevalence of alopecia areata in the United States, Clinical, Cosmetic and Investigational Dermatology 2020. Lee HH et al. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: A systematic review and meta-analysis, J Am Acad Dermatol. 2020 Mar; 82(3): 675-682. Fricke et al. Epidemiology and burden of alopecia areata: a systematic review, Clin Cosmet Investig Dermatol. 2015 Jul 24;8: 397-403. About Sun Pharmaceutical Industries Limited. (CIN - L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Contacts: Sun Pharma SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug ApprovalPhase 2License out/in

05 Aug 2024

·www.echemi.com

The Blessing for 147 Million 'Hair Loss People': JAK Inhibitors Breakthrough in Alopecia Areata Treatment

In the bright river of stars in the field of medicine, a new star is rising slowly, which has lit up the light of hope for countless patients with alopecia areata. Recently, Sun Pharma announced that its innovative drug Leqselvi (deuruxolitinib) was successfully approved by the US Food and Drug Administration (FDA), officially entering the battlefield of treating severe alopecia areata in adults. This milestone achievement not only marks a new era of precise targeting of cytokines in the treatment of alopecia areata, but also brings unprecedented treatment hope to the 147 million patients worldwide who are affected by alopecia areata. Alopecia areata, behind this seemingly simple word, actually hides the bitterness and helplessness of countless patients. As a common inflammatory non-scarring alopecia, alopecia areata (AA) not only seriously affects the appearance of patients with its unique symptoms of 'scratching the head', but also virtually erods their mental health and quality of life. In China, about 4 million people are suffering from the pain and inconvenience caused by alopecia areata, and they yearn to regain their hair, confidence and dignity. In retrospect, the treatment of AA has been full of bumps and challenges. For a long time, glucocorticoids, as the main treatment for alopecia areata, can relieve the disease to a certain extent, but the adverse reactions caused by its long-term use have discouraged patients. Uncertainty about efficacy, recurrent nightmares, and, in severe cases, the absence of hair growth on the entire scalp or even the whole body, have driven patients with alopecia areata into deep despair. However, scientific progress never stops. With the deepening of the research on the pathogenesis of alopecia areata, scientists have gradually unveiled the mystery of this stubborn disease. Studies have found that key pathogenic factors such as IFN-γ and IL-15 play an important role in the pathogenesis of alopecia areata. They activate the JAK-STAT pathway, which triggers a series of immune responses, leading to hair follicle damage and hair loss. This major discovery provides a new idea for the treatment of alopecia areata by blocking the effect of pathogenic factors by inhibiting JAK signaling pathway, so as to achieve precision treatment. In this context, JAK inhibitors emerged and quickly became the new darling in the field of AA treatment. At present, three JAK inhibitors have been successfully approved for the indication of AA worldwide, providing more treatment options for patients with AA. Leqselvi from Sun Pharmaceutical stands out with its excellent efficacy and safety, and has become a bright pearl in the field of alopecia areata treatment. The approval of Leqselvi not only means that patients with alopecia areata will usher in more accurate and effective treatment methods, but also heralds the arrival of a new era of alopecia areata treatment. By precisely targeting the JAK-STAT pathway that key pathogenic factors such as IFN-γ and IL-15 depend on, this innovative drug effectively blocks the progression of the disease and brings significant therapeutic effects to patients. Clinical trial data show that Leqselvi has shown encouraging efficacy and safety in the treatment of severe alopecia areata, bringing hope to many patients for hair regrowth. With the extensive application and in-depth study of JAK inhibitors such as Leqselvi, we have reason to believe that the persistent disease of alopecia areata will no longer be an invincible enemy. A new, targeted treatment is sure to help restore confidence and dignity to the 147 million people with hair loss. Let's look forward to this day.

Drug Approval

02 Aug 2024

·www.drugs.com

FDA Approves Leqselvi for Severe Alopecia

FRIDAY, Aug. 2, 2024 -- The U.S. Food and Drug Administration has approved Leqselvi (deuruxolitinib) tablets for the treatment of adults with severe alopecia areata. Leqselvi (8 mg) is a twice-daily oral selective inhibitor of the Janus kinases JAK1 and JAK2. In trials, the three most common adverse events were headache, acne, and nasopharyngitis. The approval was based on data from the THRIVE-AA1 and THRIVE-AA2 randomized, double-blind, placebo-controlled phase 3 clinical trials, which enrolled a total of 1,220 patients with alopecia areata who had at least 50 percent scalp hair loss for more than six months. Over 24 weeks, more than 30 percent of patients taking Leqselvi experienced ≥80 percent scalp hair coverage (Severity of Alopecia Tool [SALT] ≤20). Up to one-quarter of patients had almost all of their scalp hair back at 24 weeks (≥90 percent coverage). The number of Leqselvi-treated patients achieving a SALT score ≤20 did not plateau through 24 weeks. "For many people with severe alopecia areata, early intervention with effective treatment is critical," Natasha Mesinkovska, M.D., Ph.D., from the University of California, Irvine, and an investigator in the Leqselvi clinical development program, said in a statement. "An oral JAK that delivers proven results will be impactful for the alopecia areata community." Approval of Leqselvi was granted to Sun Pharma. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Deuruxolitinib Phosphate

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Alopecia Areata	US	Sun Pharmaceutical Industries, Inc.	25 Jul 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Liver Diseases	Phase 1	US	Concert Pharmaceuticals, Inc.	01 Jun 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04797650 \| NCT04518995 (AA-2, FDA_CDER) Manual	Phase 3	Alopecia Areata	1,209	Placebo twice daily (Trial AA-1)	dnnipjxcnk(tirarsldqy) = hmwmfvjkbi inoaahowmn (rgaikfdxjj ) View more	Positive	25 Jul 2024
				LEQSELVI 8 mg twice daily (Trial AA-1)	dnnipjxcnk(tirarsldqy) = yucmblthnq inoaahowmn (rgaikfdxjj ) View more
NCT04797650 (THRIVE-AA2, EADV2023)	Phase 3	Alopecia Areata	517	Deuruxolitinib 8 mg BID	kgksbbuwou(sowmptdsey) = xsaruwgzce gjcqtetgkj (oewgqxkhpy )	Positive	11 Oct 2023
				Deuruxolitinib 12 mg BID	kgksbbuwou(sowmptdsey) = usglqzvcce gjcqtetgkj (oewgqxkhpy )
NCT04797650 (AA-2 \| THRIVE-AA2, CTgov)	Phase 3	Alopecia Areata	517	CTP-543 matching placebo (Placebo)	hifaozogdy(pxtcylvnls) = hmdvzabrke eiwqpevorl (ufevviilyw, fdcfkbihrw - agqtojqzzy) View more	-	03 Jul 2023
				CTP-543 (CTP-543 8 mg BID)	hifaozogdy(pxtcylvnls) = rptqxmrhwy eiwqpevorl (ufevviilyw, dglcsmpefv - ezldtfccou) View more
NCT04518995 (AA-1 \| THRIVE-AA1, CTgov)	Phase 3	Alopecia Areata	706	CTP-543 matching placebo (Placebo)	gzzqffhfkq(xoycpfydkd) = rbjlmshuqk zbzcoajnwd (ionzugwpxp, uxiwtizmuh - vnyvufzvvw) View more	-	03 May 2023
				CTP-543 (CTP-543 8 mg BID)	gzzqffhfkq(xoycpfydkd) = situqcibvo zbzcoajnwd (ionzugwpxp, sazgyjcujn - dsivgpgafx) View more
NCT03941548 (CTgov)	Phase 2	Alopecia Areata	66	CTP-543 Matching Placebo+CTP-543 (CTP-543 12 mg BID)	gbzwmunrjo(jssdgbuogp) = nthbyerlzg wftllkblgq (lktepzqrkx, imdasnkgfe - mxwyqhozjv) View more	-	05 Apr 2023
				CTP-543 Matching Placebo+CTP-543 (CTP-543 24 mg QD)	gbzwmunrjo(jssdgbuogp) = ovkrbbbicu wftllkblgq (lktepzqrkx, fskdonuiov - oqgkcsnkuk) View more
THRIVE-AA1 (AAD2023)	Phase 3	Alopecia Areata	706	Placebo	vhhtxelbks(edbuqlpmmj) = njqgzfhqar alaycdehut (iiqgjwliim )	-	17 Mar 2023
				CTP-543 8 mg BID	vhhtxelbks(edbuqlpmmj) = pojzkrrgys alaycdehut (iiqgjwliim )
NCT03811912 (CTgov)	Phase 2	Alopecia Areata	57	CTP-543 (CTP-543 8 mg BID)	znpajwauou(rxvrqnjxlm) = zejvvdgctj zepvasaddd (jlpvadncwc, bnbazxqgae - ifzlvhdjzo) View more	-	09 Dec 2022
				CTP-543 (CTP-543 16 mg QD)	znpajwauou(rxvrqnjxlm) = rgxgfdqpzr zepvasaddd (jlpvadncwc, jthaymcrnl - qmkyxdpcse) View more
THRIVE-AA1 (EADV2022)	Phase 3	Alopecia Areata	706	CTP-543 8 mg BID	ssxnbyhnty(fekegbaeii) = lexovjfaib kqueyltfrk (mqpejrdslr, <0.0001) View more	Positive	07 Sep 2022
				CTP-543 12 mg BID	ssxnbyhnty(fekegbaeii) = svsrxzqsto kqueyltfrk (mqpejrdslr, <0.0001) View more
NCT03137381 (CTgov)	Phase 2	Alopecia Areata	149	CTP-543 matching placebo (Combined Placebo)	ngkhgvbmrz(fbmjkqhmat) = kjgzzoaaqo suxpehksjl (pjytnxtilq, alhqzdwyjg - mzaeqtaeep) View more	-	19 Jul 2022
				CTP-543 (Cohort 1: CTP-543 4 mg BID)	ngkhgvbmrz(fbmjkqhmat) = oartkfpark suxpehksjl (pjytnxtilq, tdyxhvgogl - xptojpdjhk) View more
NCT03137381 (BusinessWire) Manual	Phase 2	Alopecia Areata	104	ctp-543	jmiumnqoni(isagxntmem) = fzcxtrszda xsbisflufb (ktfzuvqycs )	Positive	01 Mar 2019
				Placebo	jmiumnqoni(isagxntmem) = pyvjtuxmgn xsbisflufb (ktfzuvqycs )

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