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

Oligoarticular ArthritisPolyarticular Juvenile Idiopathic ArthritisAnkylosing Spondylitis+ [15]

Inactive Indication

Allograft RejectionCOVID-19Crohn Disease+ [14]

Originator Organization

Pfizer Inc.

Active Organization

Pharmacia & Upjohn

Pfizer Australia Pty Ltd.

Pfizer Inc.

+ [13]

Inactive Organization

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

434

Clinical Trials associated with Tofacitinib Citrate

NCT06698822 / Not yet recruitingPhase 2IIT

A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, and IIA

To study the safety and effectiveness of tofacitinib 2% cream in treating early-stage CTCL.

Start Date06 May 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT06654882 / Not yet recruitingPhase 3IIT

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

This study is an open-label, randomized, multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi (Tumor Necrosis Factor inhibitor) medications to a second TNFi (active control) within a sequential multiple assignment randomized trial design with 2 randomization stages corresponding with clinical decision points. The first randomization addresses whether each of the 3 non-TNFi medications is superior to treatment with a second TNFi. The second randomization allows identification of optimal sequential use of biologics (treatment strategies).

Start Date01 Feb 2025

Sponsor / Collaborator

Duke University

[+1]

CTRI/2024/11/076876 / Not yet recruitingNot Applicable

Efficacy of oral tofacitinib in the treatment of nail lichen planus: a pilot clinical trial - NIL

Start Date20 Jan 2025

Sponsor / Collaborator

All India Institute of Medical Sciences

100 Clinical Results associated with Tofacitinib Citrate

100 Translational Medicine associated with Tofacitinib Citrate

100 Patents (Medical) associated with Tofacitinib Citrate

3,014

Literatures (Medical) associated with Tofacitinib Citrate

01 Jan 2025·FITOTERAPIA

Assessment of lapachol's anti-inflammatory effectiveness in mitigating sepsis-induced acute lung injury

Article

Author: Siddh, Snigdha ; Nunia, Vandana ; Khandelwal, Poonam ; Nair, Rashmy ; Joshi, Kavita ; Singh, Vaishnavi ; Qureshi, Sameer ; Chatterjee, Samit

Sepsis-induced Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) pose life-threatening risks due to an excessive activation of proinflammatory cytokines via the JAK pathway. Currently, no confirmed drug treatment exists for ALI. In this study, we explored JAK1 as a potential therapeutic target to address this issue. This study evaluates lapachol, a bioactive secondary metabolite, for its potential in treating sepsis-induced Acute Lung Injury (ALI). Lapachol was selected based on in-silico analyses such as binding energy, RMSD, RMSF, H-bond graphs, and lig plots supported the hypothesis that Lapachol binds to JAK1 in a manner similar to Tofacitinib JAK1/3 inhibitor (Positive control). Lapachol, derived from the heartwood of Tecomella undulata, was used in this investigation. Swiss albino mice were categorized into control, LPS treated, positive control (Tofacitinib), and experimental groups (Lapachol at 20 and 40 mg/kg doses). Throughout the experiment, mice behaviour was monitored, and euthanasia was performed at 12 and 24-h intervals. Various analyses, including body weight, W/D ratio, lung weight/body weight ratio, flow cytometry of BAL fluid (at 12 and 24 h), histology, myeloperoxidase assays were performed. Results indicated that both Tofacitinib and Lapachol significantly reduced ALI markers, including lung weight/body weight ratio, cell counts, and granulocytes in bronchoalveolar lavage fluid. Moreover, histopathology and MPO analysis suggested that Lapachol, particularly at 40 mg/kg, exhibited anti-inflammatory effects comparable to Tofacitinib. Conclusively, the findings suggest that Lapachol possesses the potential to inhibit JAK1 kinase domains and mitigate ALI associated with sepsis similar to Tofacitinib.

31 Dec 2024·The Journal of dermatological treatment

A case of generalized eosinophilic pustular folliculitis: treatment with JAK inhibitor

Article

Author: Zheng, Chunzhi ; Liu, Hong ; Zhou, Guizhi ; Yu, Yueqian

AIM:

This case study aims to report the efficacy and safety of a Janus kinase (JAK) inhibitor in the treatment of generalized eosinophilic pustular folliculitis (EPF).

METHODS:

We present a case of a 16-year-old Chinese patient who had been suffering from EPF for two years and had shown no response to both topical and systemic glucocorticoids. The patient was subsequently treated with oral tofacitinib at a dosage of 5mg daily.

RESULTS:

Significant remission of eruption and pruritus was observed in the patient upon treatment with tofacitinib. However, a relapse occurred upon dose reduction. Subsequent switch to the highly selective JAK1 inhibitor upadacitinib resulted in complete recovery, with the patient achieving a symptom-free status after six months.

CONCLUSIONS:

JAK inhibitors show promise as a potential treatment option for EPF patients who do not respond to traditional therapies.

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 ; Sharma, Yuvraj ; Alzahrani, Zeyad ; Anwar, Ali ; Husain, Waleed ; Mohamed, Omneya ; Hamad, Tharwat M. ; Al-Abdulkarim, Hana ; Al Omari, Bedor ; Attar, Suzan M. ; Alsaqa’aby, Mai ; 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.

212

News (Medical) associated with Tofacitinib Citrate

12 Dec 2024

·endpts.com

Handful of 'unsupported' drug price increases added $800M to US costs, ICER claims

The Institute for Clinical and Economic Review on Thursday released a new report arguing that US healthcare costs rose by more than $800 million from price increases on just five drugs’ net prices, hikes that weren’t backed by new clinical evidence. The five drugs with these “unsupported price increases,” ICER says, include Gilead’s HIV/AIDS drug Biktarvy, J&J’s multiple myeloma drug Darzalex, Novartis’ heart drug Entresto, which is one of the first drugs under government price negotiation in 2026, Exelixis’ cancer drug Cabometyx, and Pfizer’s Xeljanz, which can treat inflammatory and autoimmune conditions. To select the top 10, the group looked at 250 drugs, chosen because of their 2023 net sales revenue. It also flagged five drugs with new evidence backing their use that didn’t make the “unsupported” list, but emphasized that those “should not be interpreted to mean that the new evidence justifies the level of price increase; a full cost-effectiveness assessment was not conducted to determine the comparative value.” The topic, and ICER’s list, routinely generate pushback from drug companies that disagree with how the review is conducted. The National Pharmaceutical Council, a drug industry trade group, argued that the reports “do more harm than good: They have serious methodological limitations, contradict ICER’s core value assessment framework, and ignore a tremendous amount of evidence submitted by manufacturers.” Kimberly Westrich, NPC chief strategy officer, told Endpoints News by email, “We continue to call on ICER to stop producing this consistently flawed report that misleads stakeholders and risks driving harmful policy decisions.”

29 Nov 2024

·www.prnewswire.com

Minghui Pharmaceutical Announces Positive Topline Results from Phase Ⅲ Trial of MH004 (Tofacitinib Etocomil) Ointment in Mild to Moderate Atopic Dermatitis

SHANGHAI, Nov. 29, 2024 /PRNewswire/ -- Minghui Pharmaceutical, a late-stage biopharmaceutical company dedicated to developing transformative medicines in immunology and oncology, today announced positive topline results from its phase Ⅲ trial of MH004 (tofacitinib etocomil) ointment 1.0%, a twice-daily pan-Jak inhibitor, in adolescents (ages 12 years and older) and adults with mild to moderate atopic dermatitis (AD). This multicenter, double-blind, randomized, vehicle-controlled phase Ⅲ clinical trial was conducted to evaluate the efficacy and safety of MH004 1.0% in adolescents and adults with mild to moderate AD. A total of 377 participants were randomized 2:1 to receive either MH004 1.0% or Vehicle BID with an 8-week treatment period, followed by 44-week open-label extension for long-term safety. The primary endpoints were the proportion of participants achieving IGA-TS (Investigator Global Assessment (IGA) of 'clear' or 'almost clear' with a 2-grade improvement) at Week 4 and the proportion achieving a 75% improvement in Eczema Area and Severity Index (EASI-75) at Week 4. Key efficacy results are as follows: IGA-TS at Week 4 41.0% of individuals treated with MH004 1.0% achieving IGA-TS at Week 4 compared to 10.3% treated with vehicle (P<0.0001). EASI-75 at Week 4 58.2% of individuals treated with MH004 1.0% achieving EASI-75 at Week 4 compared to 19.8% treated with vehicle (P<0.0001). Additionally, the key secondary endpoints, including IGA-TS and EASI-75 at week 8, as well as the proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS4) score at week 8, were successfully met. MH004 1.0% demonstrated statistically significant improvements across all these parameters compared to the vehicle. MH004 1.0% was well-tolerated, with a safety profile consistent with findings from the previous Phase II study. All TRAEs were mild to moderate (grade 1 or 2) in severity. No drug-related serious adverse events (SAEs) were reported. "We are thrilled with the positive topline results from the Phase Ⅲ study. MH004 showed significant symptom improvement in patients with atopic dermatitis and was well-tolerated." said Guoqing Cao, Ph.D., Chief Executive Officer of Minghui Pharmaceutical. "The rapid onset of action observed with MH004 is particularly valuable for patients. These findings reinforce MH004's potential as a meaningful addition to current treatment options for atopic dermatitis, addressing both safety and efficacy needs. Moreover, MH004's benefits may extend to other inflammatory skin diseases as well. In our ongoing phase Ⅱ for vitiligo, we have seen convincing PoC, and the preliminary efficacy data looks highly encouraging." Dr. Cao continued, "I would like to extend my sincere gratitude to all the patients who participated in the trial, as well as to the physicians and staff for their dedicated work. Their contributions were essential to the success of this trial. We look forward to working with regulators to make this treatment available to patients as soon as possible." "Atopic dermatitis is a chronic inflammatory condition, particularly prevalent in children, underscoring the urgent need for effective, fast-acting topical therapies beyond corticosteroids." said Jianzhong Zhang, M.D., lead investigator in the Phase 3 trial and Professor of Peking University People's Hospital. "While corticosteroids are reasonably effective, their long-term use is often limited due to local side effects and safety concerns. MH004 demonstrated superior clinical efficacy in this pivotal phase Ⅲ study, achieving the co-primary endpoints of IGA-TS and EASI-75. The treatment also exhibited a favorable safety profile, and as the leading PI of this study, I am highly encouraged by these results and optimistic about MH004's potential to advance AD care." About Minghui Pharmaceutical Minghui Pharmaceutical, established in 2018, is a late-stage biopharmaceutical company committed to developing innovative therapies for unmet medical needs in oncology and autoimmune diseases. Leveraging expertise in medical science and proprietary technology platforms, the company is advancing a robust clinical-stage pipeline that features a range of first-in-class or best-in-class product candidates. For more information, please visit . About MH004 Ointment MH004 (tofacitinib etocomil) ointment is a topical product containing a JAK inhibitor that was designed and formulated with Minghui's proprietary technologies. MH004 is expected to have much improved skin permeability to achieve extensive target inhibition in local skin tissues without systemic toxicities that have been widely reported for oral JAK inhibitors. MH004 is intended to be used for the treatment of multiple dermatologic autoimmune diseases. Forward-Looking Statements This press release provided by Minghui Pharmaceutical Inc. (the "Company") contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "predict," "should," "will," "would" or words of similar meaning. These statements are based on the Company's current beliefs and expectations and subject to risks and uncertainties that may cause actual results to differ materially from those set forth in the statements herein. Risks and uncertainties include but not limited to: general industry conditions and competition; changes in economic and financial conditions of the Company's and the collaborators' businesses; the risk that clinical trials are discontinued or delayed for any reasons, including for efficacy, safety, enrollment, or manufacturing; the risk that success in early stage clinical trials may not be predictive of results in later stage trials or trials of other potential indications; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials; expectations for regulatory approvals; challenges to obtain, maintain and enforce patents and other intellectual property protection for the Company's product(s) and product candidate(s). These forward-looking statements speak only as of the date they are posted to this website, and the Company undertakes no obligation to update any forward-looking statements contained herein. SOURCE Minghui Pharmaceutical, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2

25 Nov 2024

·www.globenewswire.com

Novartis highlights new 96-week results from Phase III Scemblix® ASC4FIRST trial at ASH and late-breaking analysis from Phase III Kisqali® NATALEE trial at SABCS

Longer-term 96-week results from Scemblix® ASC4FIRST Phase III study in first-line Ph+ CML-CP to be presented following recent FDA approval based on 48-week data Late-breaking Kisqali®* 4-year analysis on distant disease-free survival in key subgroups with HR+/HER2- early breast cancer from Phase III NATALEE trial also to be presentedPipeline updates demonstrate advancement in research and development programs in hematologic diseases and cancers Basel, November 25, 2024 – Novartis will present data from more than 65 abstracts, including investigator-initiated trials at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition and the 2024 San Antonio Breast Cancer Symposium® (SABCS). “By prioritizing research in areas of greatest medical need and focusing on earlier stages of disease, we aim to change the treatment paradigm for people who require additional treatment options,” said Jeff Legos, Executive Vice President, Global Head of Oncology Development, Novartis. “The new data being presented at ASH and SABCS underscore our commitment to patients with cancer or blood disorders and follow new, expanded indications for Scemblix and Kisqali along with recent updates in national treatment guidelines." In addition to late-breaking data, Novartis will host an art gallery-style exhibit at SABCS featuring personal letters and stories written by people impacted by breast cancer, sharing their raw, authentic perspectives on aspects of the breast cancer journey. These letters and stories aim to uplift patients, encourage reflection, and demonstrate strength and unity among the breast cancer community. Key abstracts accepted by ASH include: Medicine or Disease State      Abstract Title      Abstract Number/ Presentation Details       Scemblix®Asciminib (ASC) Demonstrates Favorable Safety and Tolerability Compared with Each Investigator-Selected Tyrosine Kinase Inhibitor (IS TKI) in Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP) in the Pivotal Phase 3 ASC4FIRST Study Abstract #475Oral PresentationSunday, December 89:30 – 11:00 AM PTScemblix   Efficacy and Safety of Asciminib in Chronic Myeloid Leukemia in Chronic Phase (CML-CP): Interim Results from the Phase 2 ASC2ESCALATE Trial in the Cohort of Patients (Pts) after 1 Prior Tyrosine Kinase Inhibitor (TKI) Abstract #479Oral PresentationSunday, December 89:30 – 11:00 AM PTScemblix Asciminib Shows High Efficacy and Favorable Tolerability at 80 Mg Once Daily and 40 Mg Twice Daily in Patients with Chronic Phase Chronic Myelogenous Leukemia Previously Treated with 2 or More Tyrosine Kinase Inhibitors: Primary Analysis from the ASC4OPT Study Abstract #4526Poster PresentationMonday, December 96:00 – 8:00 PM PTScemblix Treatment with Asciminib as a Second Line after One Prior Tyrosine Kinase Inhibitor (TKI) in Patients with Chronic-Phase Chronic Myeloid Leukemia (CML-CP)– a Chart Review Study in the United States Abstract #3812Poster PresentationSunday, December 86:00 – 8:00 PM PTIanalumab (VAY736)A Phase 2 Study of Ianalumab in Patients with Primary Immune Thrombocytopenia Previously Treated with at Least Two Lines of Therapy: Interim Results from VAYHIT3 Abstract #710Oral PresentationMonday, December 910:30 AM – 12:00 PM PTRapcabtagene autoleucel (YTB323)Rapcabtagene Autoleucel (YTB323) in Patients (Pts) with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL): Phase II Trial Clinical Update Abstract #67Oral PresentationSaturday, December 79:30 – 11:00 AM PTFabhalta®Oral Iptacopan Monotherapy Leads to Long-Term Improvements in Patient (Pt)-Reported Health-Related Quality of Life (HRQoL) and Investigator-Assessed Signs and Symptoms of Paroxysmal Nocturnal Hemoglobinuria (PNH): 48-Week (Wk) Results from the Phase III APPLY-PNH and APPOINT-PNH Trials Abstract #4079Poster PresentationMonday, December 96:00 – 8:00 PM PTFabhalta The Effect of Oral Iptacopan Monotherapy on Hematological Parameters in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Is Consistent Regardless of the Type of Prior Anti-C5 Treatment Received: A Post Hoc Analysis of 24-Week Data from the Randomized Phase III APPLY-PNH Trial Abstract #4087Poster PresentationMonday, December 96:00 – 8:00 PM PTFabhalta Baseline Characteristics of Individuals with Paroxysmal Nocturnal Hemoglobinuria in an App-Based Home-Reported Outcomes Study to Evaluate Disease Burden Abstract #2327Poster PresentationSaturday, December 75:30 – 7:30 PM PTPelabresib (CPI-0610)Updated Results from the Phase 3 Manifest-2 Study of Pelabresib in Combination with Ruxolitinib for Janus Kinase Inhibitor–Naïve Patients with MyelofibrosisAbstract #3178Poster PresentationSunday, December 86:00 PM - 8:00 PM PT Key abstracts accepted by SABCS include: Medicine or Disease State      Abstract Title      Abstract Number/ Presentation Details       Kisqali® (ribociclib)* Distant disease-free survival (DDFS) across key subgroups from the phase 3 NATALEE trial of ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) in patients with HR+/HER2- early breast cancer (EBC) Abstract #P4-09-22Poster SessionThursday, December 125:30 – 7:30 PM CST Kisqali     Impact of ribociclib dose reduction on efficacy in patients with hormone receptor– positive/human epidermal growth factor receptor 2–negative (HR+/HER2-) early breast cancer (EBC) in NATALEE Abstract #P1-11-16Poster Session Wednesday, December 1112:30 – 2:00 PM CSTKisqali Risk of recurrence in real-world (RW) NATALEE- and monarchE-eligible populations of patients with HR+/HER2- early breast cancer (EBC) in an electronic health record (EHR)-derived database Abstract #P2-12-02Poster SessionWednesday, December 115:30 – 7:00 PM CST Kisqali Tolerability of First-Line (1L) Treatment (tx) With Ribociclib (RIB) for Metastatic Breast Cancer (MBC) Using 2 Large US Data Sources Abstract #P3-10-14Poster SessionThursday, December 1212:30 – 2:00 PM CST Kisqali Impact of body mass index (BMI) on the safety and efficacy of ribociclib (RIB) in patients (pts) with HR+/HER2- advanced breast cancer (ABC): pooled analysis of the MONALEESA (ML)-2, -3, and -7 trials Abstract #P2-09-20Poster SessionWednesday, December 115:30 – 7:00 PM CST Kisqali First-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in clinically aggressive HR+/HER2- advanced breast cancer (ABC): a subgroup analysis of RIGHT Choice by intrinsic subtype & gene & signature expression Abstract #PS2-06Poster PresentationThursday, December 127:00 – 8:30 AM CST Product Information     For full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartis.com/about/products. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. # # # * Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals. Novartis Media RelationsE-mail: media.relations@novartis.com Central North America Anja von Treskow+41 79 392 9697Michael Meo+1 862 274 5414Anna Schäfers+41 79 801 7267 SwitzerlandSatoshi Sugimoto +41 79 619 2035 Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Central North America Isabella Zinck+41 61 324 7188Sloan Simpson+1 862 345 4440Nicole Zinsli-Somm+41 61 324 3809Jonathan Graham+1 201 602 9921Imke Kappes+41 61 324 8269Parag Mahanti+1 973 876 4912

Phase 3Clinical ResultPhase 2ASH

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
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
Polyarticular Juvenile Idiopathic Arthritis	EU	Pfizer Europe MA EEIG	22 Mar 2017
Polyarticular Juvenile Idiopathic Arthritis	IS	Pfizer Europe MA EEIG	22 Mar 2017
Polyarticular Juvenile Idiopathic Arthritis	LI	Pfizer Europe MA EEIG	22 Mar 2017
Polyarticular Juvenile Idiopathic Arthritis	NO	Pfizer Europe MA EEIG	22 Mar 2017
Ankylosing Spondylitis	AU	Pfizer Australia Pty Ltd.	05 Feb 2015
Arthritis, Psoriatic	AU	Pfizer Australia Pty Ltd.	05 Feb 2015
Colitis, Ulcerative	AU	Pfizer Australia Pty Ltd.	05 Feb 2015
Juvenile Idiopathic Arthritis	AU	Pfizer Australia Pty Ltd.	05 Feb 2015
Rheumatoid Arthritis	US	PF Prism CV	06 Nov 2012

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 Multiforme	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	Huizhi Pharmaceutical (Dalian) Co., Ltd.	10 May 2018
Systemic onset juvenile chronic arthritis	Phase 3	US	Pharmacia & Upjohn	10 May 2018
Systemic onset juvenile chronic arthritis	Phase 3	US	Pfizer Inc.	10 May 2018
Systemic onset juvenile chronic arthritis	Phase 3	CN	Pfizer Inc.	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


ACAAI2024	Not Applicable	Psoriasis IL-6 \| CD4+ \| CD25- ... View more	17	Tofacitinib	hhenouspxh(nqxgubqbsh) = wsnevmqztf sngsjzdvmv (ctujyfejsf )	Positive	24 Oct 2024
UEGW	Not Applicable	-	-	Tofacitinib	oidggwadib(mxizbbntid): OR = 2.03 (95% CI, 1.3 - 3.16), P-Value = 0.002 View more	-	13 Oct 2024
UEGW	Not Applicable	-	-	Vedolizumab		-	13 Oct 2024
TOFA-UC (UEGW2024)	Not Applicable	-	171	Tofacitinib	eetxwhpbnu(wvtjlqirwv) = adhdsrlkwb jaxmgepprb (larvvmgpuz ) View more	Positive	13 Oct 2024
UEGW	Not Applicable	Colitis, Ulcerative	158	Tofacitinib	rjrfogtxbb(iaqriphhuj) = ptdlxdcbse fstggetkbd (degrcfkhob ) View more	Positive	13 Oct 2024
UEGW	Not Applicable	Colitis, Ulcerative	158	Vedolizumab	rjrfogtxbb(iaqriphhuj) = rdyhsutzfr fstggetkbd (degrcfkhob ) View more	Positive	13 Oct 2024
UEGW	Not Applicable	-	-	Tofacitinib	rbjgdqwsup(fuyhhyvldg) = one case of fever and malaise causing the withdrawal of TOFA after 3 days of administration rqunkyspvv (oivunowsjv ) View more	-	13 Oct 2024
UEGW	Not Applicable	Colitis, Ulcerative	-	Tofacitinib 10mg b.i.d.	unctudvcym(hchkfkhxqn) = vmbmytvfjc kudjohgomj (gwwooajhgi )	-	13 Oct 2024
NCT01470612 \| NCT01458951 \| NCT01458574 \| NCT03281304 (global UC clinical program, Pubmed \| United European Gastroenterol J)	Not Applicable	Colitis, Ulcerative	1,157	Tofacitinib 5 mg b.i.d.	jmzgctwyyl(hgxbicokwg) = vehuodrabz awilmgmgys (rhlioxuafl )	Positive	01 Jul 2024
	Not Applicable	Colitis, Ulcerative	1,157	Tofacitinib 10 mg b.i.d.	jmzgctwyyl(hgxbicokwg) = cpxnbtzaap awilmgmgys (rhlioxuafl )	Positive	01 Jul 2024
NCT01500551 (Pubmed)	Phase 2/3	Juvenile Idiopathic Arthritis	225	Tofacitinib 5 mg	naulfjexrb(phbgdhmdqy) = Of 225 patients with JIA (median (range) duration of treatment, 41.6 (1-103) months), 201 (89.3%) had AEs; 34 (15.1%) had serious AEs. 10 patients developed serious infections; three had herpes zoster. Two patients newly developed uveitis. uhxjzshkjn (qxrpyfcrol )	Positive	07 Jun 2024
ESCALATE-RA (EULAR2024) Manual	Not Applicable	Rheumatoid Arthritis	1,378	Tofacitinib	cslmjjhaip(btjtvfzifv) = dkssoclfye aleyiwnszu (qlklsfwoor ) View more	Positive	05 Jun 2024
EULAR2024 Manual	Not Applicable	Rheumatoid Arthritis	-	Tofacitinib	gbovhhyhiq(nywgtvyqbx) = wsokehxuwf sxmatznltw (ehwinqdisv ) View more	Negative	05 Jun 2024
EULAR2024 Manual	Not Applicable	Rheumatoid Arthritis	-	MTXtrol (MTX/cs/bDMARDs/immunosuppressants)	gbovhhyhiq(nywgtvyqbx) = dntzzhhyvl sxmatznltw (ehwinqdisv ) View more	Negative	05 Jun 2024

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