JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors), JAK2 inhibitors(Tyrosine-protein kinase JAK2 inhibitors), JAK3 inhibitors(Tyrosine-protein kinase JAK3 inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesDigestive System Disorders+ [6]

Active Indication

Ankylosing SpondylitisArthritis, PsoriaticColitis, Ulcerative+ [13]

Inactive Indication

Allograft RejectionCOVID-19Crohn Disease+ [9]

Originator Organization

Pfizer Inc.

Active Organization

Pfizer Inc.Pfizer Europe MA EEIGTWi Biotechnology, Inc.

+ [9]

Inactive Organization

Overseas Pharmaceuticals Ltd.Pfizer Manufacturing Deutschland GmbH

Drug Highest PhaseApproved

First Approval Date

US (06 Nov 2012),

Rheumatoid Arthritis

RegulationPriority Review (CN), Special Review Project (CN)

Structure

Molecular FormulaC22H28N6O8

InChIKeySYIKUFDOYJFGBQ-YLAFAASESA-N

CAS Registry540737-29-9

417

Clinical Trials associated with Tofacitinib Citrate

NCT06465732 / Not yet recruitingPhase 4

A Randomized Controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Combination With Short-term Low-dose Tofacitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

Atopic dermatitis (AD) is a common chronic inflammatory skin disease characterized by intense pruritus and sleep disturbances. The clinical manifestations of AD are varied, with the most basic features being dry skin, chronic eczema-like dermatitis, and intense pruritus. The prevalence in children and adults is about 30% and 10%, respectively. Most patients respond well to topical anti-inflammatory drugs, but approximately 10 percent of patients with moderate-to-severe AD require one or more systemic therapies to achieve good disease control. Although nonspecific immunosuppressive drugs (including glucocorticoids, cyclosporine A, methotrexate, azathioprine, or mycophenolate mofetil) are effective in alleviating or controlling these disorders to some extent, their overall efficacy in patients is limited and associated with significant side effects with long-term use.
The main hallmarks of systemic type II inflammation are eosinophilia and elevated serum immunoglobulin E (IgE) levels. Type II inflammatory response is not only associated with allergic reactions, but is also a driver of such diseases. The release of cytokines (interleukins 4, 5, and 13) in the response to type II inflammation can trigger a lymphocyte-mediated type II inflammatory response, inducing the onset and progression of allergic diseases. Reducing the inflammatory response by inhibiting the above-mentioned inflammatory factors is a potential therapeutic means for the treatment of allergic diseases represented by AD.
Investigational drug Dupilumab injection, an interleukin-4 receptor α (IL-4Rα) antagonist, is a human monoclonal antibody that binds IL-4Rα and inhibits IL-4 and IL-13 signaling. With a molecular weight of about 147 kDa, it inhibits the signaling of interleukin 4 and interleukin 13 and blocks its signaling pathway through the atopic binding of the interleukin 4Ra subunit shared with the interleukin 4 and interleukin 13 receptor complex, and blocks their signaling pathways, which can achieve continuous, efficient and safe improvement of skin lesions, itching and other symptoms and alleviate the condition.
Tofacitinib is a Janus kinase (JAK) inhibitor. JAK is an intracellular enzyme that conducts signals generated by cytokine or growth factor-receptor interactions on cell membranes, thereby affecting cell hematopoiesis and cellular immune function.

Start Date01 Jan 2025

Sponsor / Collaborator

Second Affiliated Hospital Zhejiang University School of Medicine

NCT06393972 / Not yet recruitingPhase 2IIT

The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis: a Single-arm, Prospective, Phase 2 Trial

The efficacy and safety of Tofacitinib in patients with glucocorticoid resistant ICIs-related myocarditis: a single-arm, prospective, phase 2 trial

Start Date01 Jul 2024

Sponsor / Collaborator

Zhongshan Hospital Fudan University

NCT06095128 / RecruitingPhase 4

An Open-Label, Phase 4, Single-Arm, Multicenter Study to Evaluate the Induction of Response and Remission of Vedolizumab Dual Targeted Therapy With Tofacitinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment.
All participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks.
Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab.

Start Date12 Jun 2024

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

100 Clinical Results associated with Tofacitinib Citrate

100 Translational Medicine associated with Tofacitinib Citrate

100 Patents (Medical) associated with Tofacitinib Citrate

2,798

Literatures (Medical) associated with Tofacitinib Citrate

31 Dec 2024·Journal of medical economics

Cost-effectiveness analysis of upadacitinib as a treatment option for patients with rheumatoid arthritis in the Kingdom of Saudi Arabia

Article

Author: Al-Homood, Ibrahim ; Alsaqa'aby, Mai ; Sharma, Yuvraj ; Anwar, Ali ; Alzahrani, Zeyad ; Hamad, Tharwat M ; Mohamed, Omneya ; Husain, Waleed ; Al-Abdulkarim, Hana ; Al Omari, Bedor ; Attar, Suzan M ; Jaheen, Ahmed M

AIM:

To evaluate cost-effectiveness of upadacitinib (targeted synthetic-disease modifying anti-rheumatic drug [ts-DMARD]) as first-line (1 L) treatment versus current treatment among patients with rheumatoid arthritis (RA) in the Kingdom of Saudi Arabia (KSA), who had an inadequate response to prior conventional-synthetic (csDMARDs) and/or biologic-DMARDs (bDMARDs).

METHODS:

This Excel-based model included patients with moderate (Disease Activity Score [DAS28]: >3.2 to ≤5.1) or severe RA (DAS28 > 5.1). Cost-effectiveness of current treatment (1 L: adalimumab-originator/biosimilar; second-line (2 L): other bDMARDs/tofacitinib) was compared against a new treatment involving two scenarios (1 L: upadacitinib, 2 L: adalimumab-biosimilar [scenario-1]/adalimumab-originator [scenario-2]) for a 10-year time-horizon from societal perspective. Model outcomes included direct and indirect costs, quality-adjusted life-years (QALYs), hospitalization days, number of orthopedic surgeries, and incremental cost-utility ratio (ICUR) per QALY.

RESULTS:

With the current pathway, estimated total societal costs for 100 RA patients over 10-year period were Saudi Riyal (SAR) 50,450,354 (United States dollars [USD] 13,453,428) (moderate RA) and SAR50,013,945 (USD13,337,052) (severe RA). New pathway (scenario-1) showed that in patients with moderate-to-severe RA, upadacitinib led to higher QALY gain (+8.99 and +15.63) at lower societal cost (cost difference: -SAR2,023,522 [-USD539,606] and -SAR3,373,029 [-USD899,474], respectively). Thus, as 1 L, upadacitinib projects "dominant" ICUR per QALY over current pathway. Moreover, in alternate pathway (scenario-2), upadacitinib also projects "dominant" ICUR per QALY for patient with severe RA (QALY gain: +15.63; cost difference: -SAR 164,536 [-USD43,876]). However, moderate RA was associated with additional cost of SAR1,255,696 (USD334,852) for improved QALY (+8.99) over current pathway (ICUR per QALY: SAR139,742 [USD37,264]). Both scenarios resulted in reduced hospitalization days (scenario-1: -14.83 days; scenario-2: -11.41 days) and number of orthopedic surgeries (scenario-1: -8.36; scenario-2: -6.54) for moderate-to-severe RA over the current treatment pathway.

CONCLUSION:

Upadacitinib as 1 L treatment in moderate-to-severe RA can considerably reduce healthcare resource burden in KSA, majorly due to reduced drug administration/monitoring/hospitalization/surgical and indirect costs.

26 Feb 2024·Journal of Crohn's & colitis

Tofacitinib Versus Oral Prednisolone for Induction of Remission in Moderately Active Ulcerative Colitis [ORCHID]: A Prospective, Open-Label, Randomized, Pilot Study

Article

Author: Chawla, Avantika ; Sood, Kriti ; Singh, Arshdeep ; Singh, Dharmatma ; Sood, Ajit ; Bansal, Namita ; Mahajan, Ramit ; Kaur, Ramandeep ; Kohli, Aditya ; Kaur, Kirandeep ; Midha, Vandana

Abstract:

Background:

Oral corticosteroids are first-line agents to induce remission in moderately active ulcerative colitis [UC], but are associated with adverse effects. We compared the efficacy and safety of tofacitinib and prednisolone for induction of remission in moderately active UC.

Methods:

This was a single-centre, prospective, open-label, randomized, active-controlled pilot study. Eligible patients [aged ≥18 years] had moderately active UC. Participants were randomly assigned to receive either prednisolone [40 mg daily, tapered by 5 mg every week] or tofacitinib [10 mg twice daily] for 8 weeks. The primary endpoint was composite remission [defined as total Mayo clinic score ≤2, with endoscopic sub-score of 0 and faecal calprotectin <100 µg/g] at 8 weeks.

Results:

Seventy-eight patients were randomly assigned to either of the treatment groups. At week 8, the proportion of patients achieving composite remission in the tofacitinib [7/43, 16.28%] and prednisolone groups [3/35, 8.57%] were not significantly different (odds ratio [OR] 2.07, 95% confidence interval [CI] 0.49–8.70; p = 0.31). The time to achieve symptomatic remission [normal stool frequency with absence of rectal bleeding] was similar (10 days, interquartile range [IQR 7–18.75] and 10 days [IQR 5–12.5] for tofacitinib and prednisolone, respectively; p = 0.25) in the two groups. One patient each in the tofacitinib and prednisolone group discontinued treatment due to development of pulmonary tuberculosis and pustular acne, respectively. One patient receiving tofacitinib developed herpes zoster, but did not require cessation of therapy. No serious adverse events or major adverse cardiovascular events were observed.

Conclusion:

In patients with moderately active UC, there was no difference in the efficacy and safety of tofacitinib and oral prednisolone for induction of remission at 8 weeks.

Trail Registration:

Clinical Trials Registry of India [CTRI/2021/10/037641]

The American journal of gastroenterology

Rates of Adverse Events in Patients With Ulcerative Colitis Undergoing Colectomy During Treatment With Tofacitinib vs Biologics: A Multicenter Observational Study

Article

Author: Molnar, Tamas ; Bezzio, Cristina ; Drygiannakis, Ioannis ; Ribaldone, Davide Giuseppe ; Milla, Monica ; Eder, Piotr ; Savarino, Edoardo Vincenzo ; Castiglione, Fabiana ; Pugliese, Daniela ; Calella, Francesca ; Bouillon, Vincent ; Viola, Anna ; Armuzzi, Alessandro ; Oliveira, Raquel ; Melotti, Laura ; Dragoni, Gabriele ; Caprioli, Flavio ; Vieujean, Sophie ; Kagramanova, Anna ; Noviello, Daniele ; Festa, Stefano ; Fernandes, Samuel ; Viganò, Chiara ; Amiot, Aurelién ; Chaparro, María ; Truyens, Marie ; Gravina, Antonietta Gerarda ; Innocenti, Tommaso ; Ellul, Pierre ; Argyriou, Konstantinos

INTRODUCTION::

Patients with ulcerative colitis (UC) receiving immunosuppressive drugs are at substantial risk of colectomy. We aimed to assess the risk of postoperative complications of tofacitinib exposure before colectomy in comparison with biologics.

METHODS::

A multicenter, retrospective, observational study was conducted in patients with UC who underwent total colectomy for medically refractory disease, exposed to tofacitinib or a biologic before surgery. Primary outcome was the occurrence of any complication within 30 (early) and 90 (late) days after surgery. Secondary outcomes were the occurrence of infections, sepsis, surgical site complications, venous thromboembolic events (VTE), hospital readmissions, and redo surgery within the same timepoints.

RESULTS::

Three hundred one patients (64 tofacitinib, 162 anti-tumor necrosis factor-α agents, 54 vedolizumab, and 21 ustekinumab) were included. No significant differences were reported in any outcome, except for a higher rate of early VTE with anti-tumor necrosis factor-α agents (P = 0.047) and of late VTE with vedolizumab (P = 0.03). In the multivariate analysis, drug class was not associated with a higher risk of any early and late complications. Urgent colectomy increased the risk of any early (odds ratio [OR] 1.92, 95% confidence interval [CI] 1.06–3.48) complications, early hospital readmission (OR 4.79, 95% CI 1.12–20.58), and early redo surgery (OR 7.49, 95% CI 1.17–47.85). A high steroid dose increased the risk of any early complications (OR 1.96, 95% CI 1.08–3.57), early surgical site complications (OR 2.03, 95% CI 1.01–4.09), and early redo surgery (OR 7.52, 95% CI 1.42–39.82). Laparoscopic surgery decreased the risk of any early complications (OR 0.54, 95% CI 0.29–1.00), early infections (OR 0.39, 95% CI 0.18–0.85), and late hospital readmissions (OR 0.34, 95% CI 0.12–1.00).

DISCUSSION::

Preoperative tofacitinib treatment demonstrated a postoperative safety profile comparable with biologics in patients with UC undergoing colectomy.

166

News (Medical) associated with Tofacitinib Citrate

01 Jul 2024

·www.biospace.com

Biora Therapeutics Announces Positive Clinical Trial Results for BT-600

Drug-device combination leverages Biora’s NaviCap™ platform to deliver tofacitinib directly to colonic tissue as a potential treatment for ulcerative colitis BT-600 was well tolerated and met all trial objectives, demonstrating the NaviCapplatform’s ability to deliver therapeutics directly to the colon Drug absorption in colonic tissue extended to distal colon, suggesting pan-colonic delivery Company to host virtual event with key opinion leaders on July 17 SAN DIEGO, July 01, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today shared positive topline results from its clinical trial of BT-600, an orally administered drug-device combination in development for the potential treatment of patients with ulcerative colitis (UC). BT-600 leverages Biora’s ingestible NaviCap™ device to deliver a proprietary liquid formulation of tofacitinib directly to the colon. Results from this Phase 1 clinical trial involving 48 healthy volunteers met all trial objectives, with demonstrated drug absorption in colonic tissue that extended to the distal colon, suggesting pan-colonic delivery. Daily dosing with BT-600 was well tolerated by all participants. “Successful completion of our Phase 1 clinical trial is an important milestone for Biora,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “All study objectives were met, and we confirmed that the NaviCap platform can deliver tofacitinib topically to the colon, with lower peak systemic exposure than with conventional oral delivery. These results support our plan to advance BT-600 into our Phase 1b clinical trial in patients with UC.” “We are extremely encouraged by the results from this trial, which demonstrate the NaviCap platform’s ability to deliver drug to the location of disease, where it’s needed,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “Our anatomically targeted approach has the potential to improve the efficacy of JAK inhibitors and other drug classes. We envision a portfolio of NaviCap-delivered therapeutics unlocking new treatment potential for patients with GI diseases.” “I would like to thank the study participants, clinicians, and our Biora team for conducting such a well-executed trial,” continued Mr. Mohanty. “Our team continues to execute at a high level as we meet our NaviCap platform milestones, while the BioJet™ platform is also progressing well and is on track to meet our previously stated goals.” Summary of Key BT-600 Phase 1 Trial Results Results from the Phase 1 clinical trial demonstrate a pharmacokinetic (PK) pro with drug delivery and absorption in the colon for both single and multiple ascending dose (SAD/MAD) cohorts. First evidence of systemic absorption of tofacitinib was at six hours, consistent with colonic (vs. upper gastrointestinal) delivery. Maximal levels in the trial occurred at eight to ten hours vs. 30 minutes for conventional oral tofacitinib in other trials. Maximal systemic drug exposure was three to four times lower than that seen with conventional oral tofacitinib in other trials, demonstrating the NaviCap platform’s ability to deliver locally to the colon and limit systemic drug exposure. The distribution of colon tissue exposure suggests that pan-colonic delivery of tofacitinib was achieved. Sites in the distal colon were biopsied, following delivery of tofacitinib in the proximal colon, for evidence of tissue drug exposure Biopsy results provided evidence of drug exposure extending to the distal colon, at common sites of disease. Post-retrieval device analysis further confirmed that NaviCap devices accurately delivered drug in the colon, with 100% of devices (SAD) and 98% of devices (MAD) detecting colon entry. NaviCap devices were well tolerated by participants in both the SAD and MAD cohorts. Virtual Event Details The company will host a KOL event with members of management and its Clinical Advisory Board to provide additional details regarding the Phase 1 trial and plans for the next phase of clinical development. Date: Wednesday, July 17, 2024 Time: 2:00 PM Eastern / 11:00 AM Pacific time Live Webcast: Attendees may register in advance using the webcast link above. A replay will be available online following the event. Phase 1 Clinical Trial Design The objectives of this Phase 1 randomized, double-blind, placebo-controlled, single and multiple ascending dose (SAD/MAD) clinical trial were to evaluate the safety and pharmacokinetics of BT-600 when administered orally in healthy adult participants. The trial, which was conducted in the United States, consisted of two parts: The first part was comprised of 24 participants receiving a single ascending dose of BT-600 with tofacitinib at 5 mg or 10 mg doses or placebo. The second part was comprised of 24 participants receiving multiple ascending-doses of BT-600 with tofacitinib at 5 mg or 10 mg doses or placebo daily for 7 days. The trial is listed at clinicaltrials.gov (NCT06275464). The “other trials” referred to in the summary of the Phase 1 clinical trial results above were conducted at different times, with differences in trial design and patient populations. As a result, cross-trial comparisons cannot be made and no head-to-head clinical trials have been conducted. About BT-600 BT-600 is a drug/device combination of Biora’s NaviCap™ ingestible drug delivery device with a proprietary liquid formulation of tofacitinib, for the potential treatment of moderate to severe ulcerative colitis. The NaviCap device is orally administered and has been designed for anatomically targeted therapeutic delivery directly to the colon in this application. About the NaviCap™ Targeted Oral Delivery Platform Biora's NaviCap targeted oral therapeutics platform utilizes a novel approach that could improve patient outcomes by enabling delivery of therapeutics directly to the site of disease, increasing therapeutic activity in tissue while reducing systemic uptake. For the 1.8 million patients in the United States who suffer from inflammatory bowel disease (IBD), existing therapeutics offer less than ideal efficacy, likely because of the challenges with safely achieving sufficient drug activity in the affected tissues. Research has shown that targeted delivery of therapeutics has the potential to improve patient outcomes in IBD. The NaviCap platform uses an ingestible device designed for targeted delivery of therapeutics to improve treatment of ulcerative colitis. Once swallowed, Biora’s GItrac™ autolocation technology enables the device to autonomously identify targeted locations in the GI tract and release a therapeutic dose of up to 500µl. Studies of the NaviCap device in healthy volunteers and patients with ulcerative colitis demonstrated successful delivery to the colon regardless of variable GI conditions, in both fasted and fed states. About Ulcerative Colitis Ulcerative colitis (UC) is a type of IBD that causes chronic inflammation and damage to the colon. Common symptoms include abdominal pain, increased bowel movements, stool urgency, and rectal bleeding. Despite the availability of advanced treatments for UC, including biologics, immunomodulators, and targeted synthetic small molecules, only about 40% of patients achieve clinical remission in induction trials. Surgical intervention is needed in approximately 20% of UC patients, with up to 10% of patients requiring surgical removal of the colon. About 1.5 million people are affected with UC in the United States alone, and ~40,000 new cases are diagnosed each year. About Biora Therapeutics Biora Therapeutics is reimagining therapeutic delivery. By creating innovative smart pills designed for targeted drug delivery to the GI tract, and systemic, needle-free delivery of biotherapeutics, the company is developing therapies to improve patients’ lives. Biora is focused on development of two therapeutics platforms: the NaviCap™ targeted oral delivery platform, designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ systemic oral delivery platform, designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules. For more information, visit bioratherapeutics.com or follow the company on LinkedIn or X. Safe Harbor Statement or Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the progress and future expectations and goals of our research and development, preclinical and clinical trial activities, including those involving BT-600 and our NaviCap platform, and partnering and collaboration efforts with third parties, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “envision,” “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “anticipate,” “forward,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” “goal(s)” “target,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Such risks, uncertainties, and other factors include, among others, our ability to innovate in the field of therapeutics, our ability to make future FDA filings and initiate and execute clinical trials on expected timelines or at all, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding allowed patents or intended grants to result in issued or granted patents, our expectations regarding opportunities with current or future pharmaceutical collaborators or partners, our ability to raise sufficient capital to achieve our business objectives, our ability to maintain our listing on the Nasdaq Global Market, and those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC) and other subsequent documents, including Quarterly Reports on Form 10-Q, that we the SEC. Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. Investor Contact Chuck Padala Managing Director, LifeSci Advisors IR@bioratherapeutics.com (646) 627-8390 Media Contact Liz Robinson CG Life lrobinson@cglife.com

Clinical ResultPhase 1Immunotherapy

18 Jun 2024

·www.prnewswire.com

Pharmacy and Prescription Drug Fraud: The New York StateWide Senior Action Council's "Medicare Fraud of the Month for June"

ALBANY, N.Y., June 18, 2024 /PRNewswire/ -- The New York StateWide Senior Action Council (StateWide), an organization dedicated to advocacy for the rights of seniors in New York State, today announced its Medicare Fraud of the Month for June: Pharmacy and Prescription Drug Fraud. The StateWide Fraud of the Month is a component of the Senior Medicare Patrol (SMP), the definitive resource for New York State's senior citizens and caregivers to detect, prevent, and report healthcare fraud, errors, and abuse. StateWide is New York's grantee/administrator for this Federal Program. " Pharmacy and Prescription Drug Fraud occurs when Medicare is billed for a medication that was not received or a beneficiary is intentionally given a different prescription drug than prescribed," explained Maria Alvarez, Executive Director of StateWide. She added, "Here are some examples of Pharmacy/Prescription Drug Fraud:" Providers Billing Medicare for: Prescription drugs (including refills) that were never picked up, delivered, or even prescribed. Prescription drugs (occasionally controlled substances such as opioids) that were prescribed by a health care provider you have never seen. Medication amounts beyond the quantity you were prescribed. Different prescription drug (often more expensive) than the one you were originally prescribed or issuing you a drug that is not approved by the U.S. Food and Drug Administration (FDA). And if Pharmacies: Intentionally provide less medication than prescribed or issue expired drugs. Provide and bill for an expensive compounded medication, including topical pain creams, when a less expensive prescription was ordered by a provider. Offer gift cards or other compensation to switch prescriptions over to a specific pharmacy. Automatically refill a prescription no longer needed. A prescription not picked up is billed to Medicare. Alvarez continued, "Criminals, ranging from health care providers to drug trafficking organizations, continue to commit prescription drug fraud because it is profitable. "Unfortunately, there is a strong illegal market for prescription drugs – including controlled drugs such as opioids and expensive prescriptions such as autoimmune medications like Xeljanz. Some prescription drugs are targeted because they can be combined with recreational and illegal drugs to enhance a high or hallucinogenic effect." StateWide offers the following advice to seniors to protect themselves from Prescription and Drug Fraud: Be sure your doctor has assessed your condition before prescribing you medication. Do not give out your Medicare number or other personal information to unknown individuals requesting it for prescription drug services. Be suspicious of unsolicited calls and offers for "free" or "discount" prescription drugs. Read your Medicare Summary Notice (MSN) or Explanation of Benefits (EOB) to watch for the names of unknown providers and billing of prescriptions and other services you did not receive. If you notice a charge to your Medicare drug plan for prescriptions you did not receive (or for different drugs than the ones you were prescribed), report your concerns about possible fraud, errors, or abuse to the NYS Senior Medicare Patrol. It offers a Helpline at 800-333-4374 or visit . Counselors are ready and willing to help! The NYS SMP and its trained counselors and volunteers help educate Medicare beneficiaries in the fight against health care fraud. It also provides information and educational presentations. It is estimated that Medicare fraud costs taxpayers over $60 billion dollars nationally per year. To help combat this illicit industry StateWide announced its Fraud of the Month program in 2022 to highlight these scams being perpetrated on the State's seniors. SOURCE New York StateWide Senior Action Council, Inc.

22 May 2024

·www.globenewswire.com

Organovo Data Presented at Digestive Disease Week (DDW2024) Demonstrating Potential for FXR314 as Combination Therapy with Tofacitinib for Inflammatory Bowel Disease

May 21, 2024 -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces data from a poster presented at Digestive Disease Week (DDW2024) demonstrating the potential of the Company’s lead clinical-stage compound, FXR314, in combination with tofacitinib for treating inflammatory bowel disease (IBD) using 3D models and preclinical models. DDW2024 is being held in Washington, D.C. May 18-21, 2024. The poster, titled, “Combination therapy of the FXR agonist FXR314 with tofacitinib in models of inflammatory bowel disease” was presented on Saturday May 18, 2024, in the session “Translational application of intestinal stem cells and organoid models”. “The study highlights the synergistic benefits of combining the Company’s non-steroidal, non-bile acid FXR agonist with the JAK inhibitor tofacitinib, supporting the notion of FXR314 as both a monotherapy and as part of a combination approach in IBD”, said Dr. Fabrice Piu, Vice President of Research and Development. Key findings showed that FXR314 and tofacitinib improved various measures of intestinal barrier function, inflammation, and fibrosis at optimal concentrations. Further, when combined at sub-efficacious concentrations, FXR314 and tofacitinib combined resulted in further improvements. In addition, FXR314 alone improved measures of colon health and colon histopathology similarly to approved IBD therapies tofacitinib and IL-12/23 antagonist. Investigators arrived at these conclusions in two ways. The first used Organovo’s proprietary 3D IBD model in which multiple cell types derived from IBD patients (either Crohn’s disease or ulcerative colitis) are co-cultured. The researchers evaluated target engagement, epithelial barrier integrity, inflammation, and fibrosis in the 3D IBD model using a variety of functional assays. The other approach made use of the adoptive T-Cell transfer model, a well-accepted and predictive preclinical model of colitis, where the effects of combining FXR314 and tofacitinib were evaluated in the treatment paradigm. “We believe strongly in the opportunity with regard to FXR314 in monotherapy in IBD, but these results, our first in a combination therapy approach, are exciting,” stated Keith Murphy, Organovo’s Executive Chairman. “These results further bolster our belief in the potential of FXR314 in combination therapy, and such data will be beneficial both in terms of potential combination development and also when used in monotherapy. As these data at the prestigious Digestive Disease Week show, FXR314 has the potential to show positive results in future clinical studies when used with an already prescribed biologic by improving a patient’s outcomes relative to the use of the already prescribed therapy alone.” Organovo is a clinical stage biotechnology company that is developing drugs that are demonstrated to be effective in three-dimensional (3D) human tissues as candidates for drug development. The company’s lead molecule, FXR314, is on the path for Phase 2 investigation in inflammatory bowel disease and has potential application in metabolic liver disease and oncology. The company has proprietary technology used to build 3D human tissues that mimic key aspects of native human tissue composition, architecture, function, and disease. For more information visit Organovo's website at www.organovo.com. The content above comes from the network. if any infringement, please contact us to modify.

Phase 2Cell Therapy

100 Deals associated with Tofacitinib Citrate

External Link

KEGG	Wiki	ATC	Drug Bank
D09783	Tofacitinib Citrate	L04AA29	DB08895

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Ankylosing Spondylitis	EU	Pfizer Europe MA EEIG	22 Mar 2017
Ankylosing Spondylitis	IS	Pfizer Europe MA EEIG	22 Mar 2017
Ankylosing Spondylitis	LI	Pfizer Europe MA EEIG	22 Mar 2017
Ankylosing Spondylitis	NO	Pfizer Europe MA EEIG	22 Mar 2017
Arthritis, Psoriatic	EU	Pfizer Europe MA EEIG	22 Mar 2017
Arthritis, Psoriatic	IS	Pfizer Europe MA EEIG	22 Mar 2017
Arthritis, Psoriatic	LI	Pfizer Europe MA EEIG	22 Mar 2017
Arthritis, Psoriatic	NO	Pfizer Europe MA EEIG	22 Mar 2017
Colitis, Ulcerative	EU	Pfizer Europe MA EEIG	22 Mar 2017
Colitis, Ulcerative	IS	Pfizer Europe MA EEIG	22 Mar 2017
Colitis, Ulcerative	LI	Pfizer Europe MA EEIG	22 Mar 2017
Colitis, Ulcerative	NO	Pfizer Europe MA EEIG	22 Mar 2017
Juvenile Arthritis	EU	Pfizer Europe MA EEIG	22 Mar 2017
Juvenile Arthritis	IS	Pfizer Europe MA EEIG	22 Mar 2017
Juvenile Arthritis	LI	Pfizer Europe MA EEIG	22 Mar 2017
Juvenile Arthritis	NO	Pfizer Europe MA EEIG	22 Mar 2017
Oligoarticular Arthritis	EU	Pfizer Europe MA EEIG	22 Mar 2017
Oligoarticular Arthritis	IS	Pfizer Europe MA EEIG	22 Mar 2017
Oligoarticular Arthritis	LI	Pfizer Europe MA EEIG	22 Mar 2017
Oligoarticular Arthritis	NO	Pfizer Europe MA EEIG	22 Mar 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	NDA/BLA	CN	Pfizer Manufacturing Deutschland GmbH	06 Jan 2022
Glioblastoma	Phase 3	US	Pfizer Inc.	07 Oct 2022
Recurrent Glioma	Phase 3	US	Pfizer Inc.	07 Oct 2022
COVID-19	Phase 3	BR	Pfizer Inc.	16 Sep 2020
Systemic onset juvenile chronic arthritis	Phase 3	US	Pfizer Inc.	10 May 2018
Systemic onset juvenile chronic arthritis	Phase 3	US	Pharmacia & Upjohn	10 May 2018
Systemic onset juvenile chronic arthritis	Phase 3	US	Huizhi Pharmaceutical (Dalian) Co., Ltd.	10 May 2018
Systemic onset juvenile chronic arthritis	Phase 3	AR	Pharmacia & Upjohn	10 May 2018
Systemic onset juvenile chronic arthritis	Phase 3	AR	Huizhi Pharmaceutical (Dalian) Co., Ltd.	10 May 2018
Systemic onset juvenile chronic arthritis	Phase 3	AR	Pfizer Inc.	10 May 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04424290 (HORNBILL, NEWS) Manual	Phase 1/2	Diabetic macular ischemia	43	BI 764524 (单次给药剂量递增部分)	pqwzcekdzh(fihqrkrpvk) = 单次给药剂量递增部分，未报告。 glnrhqejzt (dqydodjpnw ) View more	Positive	10 May 2024
NCT04424290 (HORNBILL, NEWS) Manual	Phase 1/2	Diabetic macular ischemia	43	BI 764524 (多次给药部分)		Positive	10 May 2024
NCT04424290 (HORNBILL, ARVO2024) Manual	Phase 1/2	Diabetic macular ischemia	31	BI 764524	dpudrmyxpm(lvkxzjfccr) = vxjuamwacn eixlsqrfjy (ufcgrsbztf )	Positive	05 May 2024
NCT04424290 (HORNBILL, ARVO2024) Manual	Phase 1/2	Diabetic macular ischemia	12	BI 764524 0.5 mg	ppvjaecsaa(ilppmimank) = No DLEs were reported in the SRD part. ljmpdfowtj (eapnsiyzsg ) View more	Positive	05 May 2024
NCT04424290 (HORNBILL, ARVO2024) Manual	Phase 1/2	Diabetic macular ischemia	12	BI 764524 1.0 mg		Positive	05 May 2024
NCT06275464 (GlobeNewswire) Manual	Phase 1	Colitis, Ulcerative	-	BT-600	ftngeflgrw(cnxztjyyzl) = tiqybsmccf ipnppshhym (jcymphzufv ) View more	Positive	04 Apr 2024
NCT04580277 (CTgov)	Phase 2	Pouchitis	6	Tofacitinib 10 mg	rabhebxdzh(bpwnegrkca) = kxtforbfcj qhlweohsxv (qsaledmwig, roqhrwniiu - ghmpbwkfba) View more	-	04 Apr 2024
NCT03486457 (CTgov)	Phase 3	Arthritis, Psoriatic	204	Tofacitinib (Tofacitinib)	wevgbolrnm(woqwdwuvpb) = edjeyadrbs dmovkgpvdr (fxlkyjlulo, sgigddvnvu - xlexrfvnvd) View more	-	08 Feb 2024
NCT03486457 (CTgov)	Phase 3	Arthritis, Psoriatic	204	Placebo+Tofacitinib (Placebo Then Tofacitinib)	wevgbolrnm(woqwdwuvpb) = glzrlkcmsa dmovkgpvdr (fxlkyjlulo, unwizndohr - vbqskjkliy) View more	-	08 Feb 2024
ESMO_ASIA2023	Not Applicable	Neoplasms cardiac troponin T (cTnT)	-	Tofacitinib	cuksxbuymo(whhajrjhlr) = kxkxliviuj qcaqzhnlrf (mnqsntkqzn ) View more	Positive	02 Dec 2023
EADV2023	Not Applicable	Alopecia Areata	23	Apremilast 30mg	otipbnuyxq(ikkulsysxo) = pscresamls dfhwqcoxol (rydbzcnnpb )	Positive	11 Oct 2023
Accesswire Manual	Phase 2	Dermatitis, Atopic	-	CGB-500	ekytpoazto(hmppaqpcfv) = mbjubbvsrq ckpiyjpalt (eogfgzkavy ) Met View more	Positive	03 Aug 2023
Accesswire Manual	Phase 2	Dermatitis, Atopic	-	Vehicle	ekytpoazto(hmppaqpcfv) = dkxcaouizr ckpiyjpalt (eogfgzkavy ) Met View more	Positive	03 Aug 2023
NCT01932372 (Pubmed)	Not Applicable	Rheumatoid Arthritis	6,866	Tofacitinib	ugaefujdof(kvrfswzmtj) = nejazeidmh pseietocnz (lmnhoutkao ) View more	-	03 Jul 2023

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis