A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).

Start Date08 Apr 2025

Sponsor / Collaborator

Celgene Corp.

NCT06528665

/ RecruitingNot Applicable

A Pharmacokinetic, Safety and Tolerability Formulation Screening Comparing Corplex Ozanimod TDS to Oral Ozanimod Capsules in Healthy Adults Subjects

The goal of this clinical trial is to learn how Ozanimod drug can be administered to the healthy subjects via transdermal delivery system (TDS, patch) to achieve better drug absorption and delivery than via oral capsules (Zeposia). Researchers will compare two administered routes of Ozanimod TDS and oral Zeposia in drug pharmacokinetics, tolerability and safety. Participants will either take one capsule only or wear a patch on his/her arm for 7 days, and blood samples will be collected to measure drug concentrations and local skin reactions will be also observed.

Start Date10 Feb 2025

Sponsor / Collaborator

Corium Innovations, Inc.

100 Clinical Results associated with Ozanimod Hydrochloride

100 Translational Medicine associated with Ozanimod Hydrochloride

100 Patents (Medical) associated with Ozanimod Hydrochloride

359

Literatures (Medical) associated with Ozanimod Hydrochloride

01 Dec 2025·Lancet Regional Health-Europe

The effect of disease-modifying therapies on brain volume loss and disability accumulation in multiple sclerosis: a systematic review and network meta-analysis

Article

Author: Cagol, Alessandro ; Schaedelin, Sabine ; Sormani, Maria Pia ; Pretzsch, Roxanne ; Granziera, Cristina ; Kappos, Ludwig

Background:

Multiple treatments have demonstrated efficacy in preventing brain volume loss (BVL) in randomized controlled trials (RCTs) for multiple sclerosis (MS). However, assessing their relative effectiveness remains challenging due to limited head-to-head comparisons. Additionally, the relationship between treatment effects on BVL and disability accumulation is not established for newer therapies. This study aimed to compare the efficacy of approved disease-modifying therapies (DMTs) in reducing BVL in MS and to investigate the association between treatment effects on BVL and disability accumulation.

Methods:

In this systematic review and network meta-analysis, we included all RCTs enrolling adults with MS that evaluated FDA-approved DMTs and reported BVL outcomes over at least one year. We searched PubMed, Embase, and Cochrane from inception to September 2024. Following PRISMA guidelines, two reviewers independently extracted data on BVL, MRI lesion activity, and disability progression. We conducted a mixed-effects network meta-analysis with placebo as the reference group. Meta-regression analyses examined the association between treatment effects on BVL and disability progression, adjusting for MRI lesion activity.The primary outcome was BVL. Secondary outcomes included MRI lesion accumulation and risk of confirmed disability progression. Effect sizes were reported as the ratio of means (ROM) and hazard ratios (HRs), with 95% confidence intervals (CIs). This study is registered with PROSPERO (CRD420251034936).

Findings:

We included 33 RCTs evaluating 16 DMTs and 26,247 patients. Eight DMTs significantly reduced BVL compared to placebo, including ponesimod (ROM = 0.52; 95%-CI: 0.35-0.77), ofatumumab (ROM = 0.58; 95%-CI: 0.40-0.83), alemtuzumab (ROM = 0.63; 95%-CI: 0.49-0.83), teriflunomide (ROM = 0.71; 95%-CI: 0.52-0.97), ozanimod (ROM = 0.74; 95%-CI: 0.56-0.98), natalizumab (ROM = 0.77; 95%-CI: 0.61-0.96), siponimod (ROM = 0.77; 95%-CI: 0.60-0.98), and fingolimod (ROM = 0.83; 95%-CI: 0.71-0.96). The treatment effect on BVL was associated with the treatment effect on disability accumulation (β = 0.466; p = 0.008), and this association remained significant independently of the treatment effect on MRI activity (β = 0.422; p = 0.005).

Interpretation:

Several DMTs-including newer therapies-significantly reduce BVL, and this effect correlates with reduced disability accumulation. These findings support BVL as a meaningful treatment target in MS.

Funding:

None.

01 Nov 2025·PAIN

Ozanimod, a functional sphingosine-1-phosphate receptor 1 antagonist, restores brainstem descending pain pathways in murine models of neuropathic pain

Article

Author: Chen, Zhomou ; Squillace, Silvia ; Lauro, Filomena ; Giancotti, Luigino Antonio ; Li, Ying ; Salvemini, Daniela

Abstract:

Activation of sphingosine-1-phosphate (S1P) receptor 1 (S1PR1) in the spinal cord contributes to neuropathic pain; however, its role at supraspinal sites remains unexplored. Ozanimod is a new FDA-approved S1PR1 antagonist for multiple sclerosis. Here, we show that systemic ozanimod administration reverses behavioral hypersensitivities in male rodents induced by chronic sciatic nerve constriction and chemotherapy (oxaliplatin and paclitaxel). Moreover, bilateral ozanimod injection in the rostral ventral medulla (RVM) reversed behavioral hypersensitivities in a time-dependent manner, evincing a role for S1PR1 in the descending pain modulatory system. RNA-Seq analysis of the RVM revealed that traumatic nerve injury downregulated type I interferons (IFN-I) signaling. Intra-RVM ozanimod administration normalized IFN-I–associated gene expression levels, suggesting that S1PR1 activation mediated IFN-I signaling downregulation that, in turn, may regulate RVM descending pain pathways. In the RVM, engagement of noradrenergic and serotonergic inhibitory circuits suppressed spinal nociception. Intrathecal injection of an α2 antagonist (yohimbine) or a serotonin antagonist (methysergide) prevented the antinociceptive effects of ozanimod in both models of neuropathic pain implicating these descending inhibitory projections in S1PR1 antagonism. In contrast to the disease state, intra-RVM injection of the S1PR1 agonist SEW2871 to uninjured animals did not cause behavioral hypersensitivities, underscoring a state-dependent role of S1PR1 in nociception. Our results establish a role for S1PR1 in descending facilitation and suggest that this function may inhibit IFN-I signaling pathways. Our findings support repurposing FDA-approved functional S1PR1 antagonists as nonopioid treatments for neuropathic pain.

01 Oct 2025·AMERICAN JOURNAL OF GASTROENTEROLOGY

Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase 3 True North Clinical Trial

Article

Author: D'Haens, Geert ; Rubin, David T. ; Jain, Anjali ; Wolf, Douglas C. ; Regueiro, Miguel ; Vermeire, Severine ; Panaccione, Remo ; Lawlor, Garrett ; Dignass, Axel ; Sands, Bruce E. ; Afzali, Anita ; Osterman, Mark T. ; Ahmad, Harris A. ; Colombel, Jean-Frederic ; Loftus, Edward V. ; Wu, Hsiuanlin

INTRODUCTION::

Patients with ulcerative colitis (UC) and prior biologic failure may have reduced or delayed efficacy with subsequent advanced therapies. This analysis evaluated the efficacy and safety of ozanimod during the True North (TN) study and its open-label extension (OLE) in biologic-exposed patients with UC.

METHODS::

TN was a randomized, placebo-controlled 52-week trial (10-week induction, 42-week maintenance period). Eligible patients could enter the OLE. Clinical outcomes were assessed at TN week (W) 10 and W52 and OLE W46 and W94. Symptomatic efficacy was evaluated through induction and in the OLE until W94. Safety was assessed.

RESULTS::

This analysis included 376 biologic-exposed patients. In the placebo-controlled cohort, more ozanimod-treated patients achieved clinical response than placebo at W10 regardless of the number or type of prior biologics; patients who used 1 vs ≥2 prior biologics achieved higher efficacy rates. Efficacy rates were higher at W52 than W10 and were similar across subgroups regardless of the number or type of prior biologics. Significantly greater proportions of ozanimod vs placebo patients achieved symptomatic response by W5 (P = 0.0173) and symptomatic remission by W10 (P = 0.0207). Among biologic-exposed TN W10 ozanimod nonresponders who entered the OLE, 61% achieved symptomatic response with an extra 10 weeks of ozanimod treatment. Ozanimod efficacy was durable for ∼3 years of continuous treatment in biologic-exposed W52 clinical responders who entered the OLE. No new safety signals were observed.

DISCUSSION::

Ozanimod was effective and safe in biologic-exposed patients with UC, but these patients may require more time to respond to treatment. Clinical trial registry website and trial numbers: ClinicalTrials.gov, numbers NCT02435992 and NCT02531126.

160

News (Medical) associated with Ozanimod Hydrochloride

27 Oct 2025

·www.prnewswire.com

Icotrokinra maintains standout combination of therapeutic benefit and a favorable safety profile in once-daily pill through 28 weeks in ulcerative colitis

Building on 12-week findings, icotrokinra demonstrated clinically meaningful outcomes at Week 28 with 31.7% of patients achieving clinical remission and 38.1% showing endoscopic improvement versus placebo in the Phase 2b ANTHEM-UC study Results support Phase 3 clinical development of icotrokinra, a first-in-class targeted oral peptide that precisely blocks the IL-23 receptor, in both moderately to severely active ulcerative colitis and Crohn's disease PHOENIX, Oct. 27, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced Week 28 results from the Phase 2b ANTHEM-UC study of icotrokinra, a first-in-class investigational targeted oral peptide that precisely blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC). These results underscore the potential of icotrokinra to deliver a combination of therapeutic benefit and a favorable safety profile with once-daily oral dosing and will be featured among Johnson & Johnson's 23 accepted abstracts at the 2025 American College of Gastroenterology Annual Scientific Meeting (ACG). At Week 28, icotrokinra demonstrated sustained and clinically meaningful results, with all doses (100 mg, 200 mg and 400 mg) showing higher rates of clinical responsea, clinical remissionb, endoscopic improvementc and histologic-endoscopic mucosal improvement (HEMI)d at Week 28 compared to placebo.1 These outcomes build on Week 12 data recently presented at United European Gastroenterology (UEG) Week 2025 where all doses of icotrokinra demonstrated superiority to placebo for the primary endpoint of clinical response.2 "The ANTHEM-UC results show that targeting the IL-23 pathway with a once-daily oral therapy can provide meaningful, sustained benefit and a favorable safety profile, giving healthcare providers a potential new approach to managing this challenging disease," said Vipul Jairath, MBChB, DPhil, Professor of Medicine at Western University in Ontario, and study investigator.e "For those living with ulcerative colitis, icotrokinra could represent an important step forward in how their disease is managed." Similar proportions of participants reported adverse events and serious adverse events through Week 28 across all icotrokinra dose groups and the placebo group.1 "These exciting results show how we are harnessing our deep understanding of the IL-23 pathway to advance innovative treatments for inflammatory bowel disease that address the daily needs of patients," said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson. "With Phase 3 development now underway in both adult and adolescent patients, our aim is to establish icotrokinra as a promising therapy that could transform the treatment paradigm in ulcerative colitis and bring patients a potential new option." Based on results from the Phase 2b ANTHEM-UC study, Johnson & Johnson has initiated the ICONIC-UC Phase 3 protocol in adults and adolescents with moderately to severely active UC as well as the ICONIC-CD Phase 2b/3 protocol in adults with moderate to severely active Crohn's disease. Icotrokinra is also being studied in the pivotal Phase 3 ICONIC program in moderate-to-severe plaque psoriasis and the ICONIC-PSA 1 and ICONIC-PSA 2 studies in active psoriatic arthritis. A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in July 2025 seeking the first approval of icotrokinra for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis. Editor's notes: a. Clinical response was defined as a decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. b. Clinical remission was defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1. c. Endoscopic improvement was defined as an endoscopy subscore of 0 or 1. d. Histologic-endoscopic mucosal improvement (HEMI) was defined as histologic remission (absence of neutrophils from the mucosa in both lamina propria and epithelium, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system) and endoscopic improvement (MES of 0 or 1). e. Dr. Jairath is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. About ANTHEM-UC ANTHEM-UC (NCT06049017) is a Phase 2b multicenter, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of icotrokinra (JNJ-77242113, JNJ-2113) in patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. The study is evaluating three once-daily dosages of icotrokinra taken orally. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.3 About Ulcerative Colitis Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.4 About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to precisely block the IL-23 receptor,5 which underpins the inflammatory response in moderate-to-severe plaque psoriasis, ulcerative colitis and offers potential in other IL-23-mediated diseases.6,7 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, precise inhibition of IL-23 signalling in human T cells.8 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.9 Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.10,11,12 Icotrokinra is being studied in the Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at . Follow us at @JNJInnovMed. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding icotrokinra (JNJ-2113). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. References: 1 Jairath V., et al. Efficacy and Safety of Icotrokinra, a Targeted Oral Peptide That Selectively Blocks IL-23 Receptor Activation, In Ulcerative Colitis: Results From Week 28 of ANTHEM-UC, a Phase 2b Dose-ranging Trial. Poster 1066 at ACG Annual Scientific Meeting 2025. October 2025. 2 Abreu M., et al. Icotrokinra, a targeted oral peptide that selectively blocks IL-23 receptor activation, in moderately to severely active ulcerative colitis: week 12 results from the phase 2b, randomized, double-blind, placebo-controlled, treat-through, dose-ranging ANTHEMUC trial. Oral presentation OP206 at United European Gastroenterology Week (UEGW) 2025. October 2025. 3 Clinicaltrials.gov. A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC). Identifier NCT06049017. . Accessed February 2025. 4 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: . Accessed April 2024. 5 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8. 6 Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229. 7 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124. 8 Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14. 9 Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: . Accessed November 2024. 10 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: . Accessed November 2024. 11 Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: . Accessed November 2024. 12 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: . Accessed November 2024. SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3License out/inNDA

07 Oct 2025

·www.businesswire.com

Progentos Therapeutics Names Paul Frohna Chief Medical Officer

WATERTOWN, Mass.--(BUSINESS WIRE)--Progentos Therapeutics, a biotech company addressing the critical unmet need to regenerate myelin and restore function for patients with Multiple Sclerosis (MS) and other demyelinating diseases, today announced that Paul Frohna, MD, PhD, has been named Chief Medical Officer. Dr. Frohna brings more than two decades of leadership as a physician-scientist and deep expertise in translational medicine, clinical development, and regulatory affairs, having led the development and subsequent approval of therapeutics for MS, fibrotic disease and cancer. “Paul’s leadership in MS drug development and demonstrated ability to move novel science through the clinic and to approval, makes him a great fit as we advance our lead program for remyelination,” said Christopher Loose, PhD, Co-Founder and Chief Executive Officer of Progentos. “With a promising development candidate in hand, we are eager to begin clinical studies and to meet the need of MS patients who today have no treatments to restore and repair the myelin needed to prevent further disability.” Dr. Frohna has successfully designed and initiated translational and clinical programs for biologics, small molecules, and peptides, and has contributed to five approved medicines. He began his industry career at Genentech where he was clinical lead for the Rituxan Phase 2 program for relapsing and primary progressive MS. There he patented the use of B-cell depleting therapy for MS, which later led to the development of ocrelizumab. He went on to be Vice President of Clinical Development at Fibrogen and later the Chief Medical Officer at Profibrix, before joining Receptos as Vice President of Clinical Development and Translational Medicine, where he oversaw clinical development of ozanimod (ZEPOSIA®) for relapsing MS and other immunology programs. He subsequently held CMO roles at ImCheck Therapeutics and Endeavor Biosciences before becoming a consulting CMO for emerging biotech companies. “Developing an agent to induce remyelination of axons affected by MS is the next frontier in treating this disease. The Progentos team has shown unparalleled pre-clinical data, and I look forward to advancing its first-in-class development candidate to the clinic in the near term,” said Dr. Frohna. “In my career I have had opportunity to help develop medicines that today are part of the standard of care for MS. It is clear, however, that patients continue to need treatments to reverse and potentially repair the damage caused by MS. I believe Progentos has the potential to address this unmet need and to develop a range of other regenerative therapies with few or no treatment options.” Dr. Frohna received his medical degree from Georgetown University, a PhD in pharmacology from the University of Pennsylvania, and a pharmacy degree from the University of Texas at Austin. He is a board director for Accure Therapeutics and on the scientific and clinical advisory board for IAMA Therapeutics, which focuses on developing novel neurotherapeutics. He has been published in leading scientific journals and is an author on more than sixty publications. About Progentos Therapeutics Progentos is developing first-in-class compounds to induce endogenous oligodendrocyte progenitor cells to remyelinate axons in patients suffering from MS and other demyelinating diseases. Combining expertise in chemistry, biology and in vivo models, Progentos discovers and develops novel small-molecule drugs to regenerate tissues in patients with degenerative diseases. The company was funded by a syndicate of investors led by Forbion and has operations in Watertown, MA, USA and Naarden, The Netherlands. More information can be found at www.progentos.com.

Phase 2Executive Change

07 Oct 2025

·firstwordpharma.com

J&J gears up to move icotrokinra into Phase III after mid-stage UC win

With an FDA filing already in for its oral IL-23 blocker in plaque psoriasis, Johnson & Johnson is turning its focus to inflammatory bowel disease, preparing a Phase III programme for icotrokinra after new data showed the pill produced dose-dependent benefits and a reassuring safety profile in patients with ulcerative colitis (UC).At the United European Gastroenterology (UEG) meeting this week, the company presented results from the Phase IIb ANTHEM-UC trial, which tested three once-daily oral doses of icotrokinra in 252 patients with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy, prior biologics and/or Bristol Myers Squibb's S1P receptor modulator Zeposia (ozanimod) or approved JAK inhibitors.J&J said the study met its main goal, with 63.5% of patients on the highest 400-mg dose of icotrokinra achieving a clinical response after 12 weeks, versus 27% for placebo. Response rates were 58.1% and 54.7% for the 200-mg and 100-mg doses, respectively. Clinical response was defined as at least a 30% and two-point drop in the modified Mayo score, along with improvement in rectal bleeding or a rectal bleeding subscore of 0 or 1.Early symptom reliefAcross key secondary measures — including clinical remission, symptomatic remission and endoscopic improvement — all dose groups outperformed placebo. At the 12-week mark, 30.2% of patients on the 400-mg dose achieved clinical remission compared to 11.1% on placebo, while 46% reached symptomatic remission versus 19% for placebo. Improvements in symptomatic remission were already evident by the fourth week, J&J said. Meanwhile, endoscopic improvement was seen in 36.5% of patients in the high-dose arm, compared to a placebo rate of 14.3%.The frequency of adverse and serious adverse events was similar across all icotrokinra doses and placebo.Esi Lamousé-Smith, gastroenterology disease area lead at J&J, said in a release Tuesday that icotrokinra "marks the next chapter in our history of innovation in inflammatory bowel disease," building on the company's goal of translating IL-23 pathway biology into a targeted oral option. The drug is being co-developed with Protagonist Therapeutics.Move to Phase IIIBased on ANTHEM-UC, J&J is kicking off the Phase III ICONIC-UC trial as well as the Phase IIb/III ICONIC-CD study in Crohn's disease, both expected to begin enrolling later this month.Abivax's oral contender obefazimod may beat it to the market, however. The miR-124 enhancer also drew attention at UEG this week, showing a 29% placebo-adjusted difference in clinical response in patients who had failed up to four prior advanced therapies, according to a pooled analysis of Phase III studies.J&J's readout adds momentum to a broader programme for icotrokinra. The company recently reported favourable head-to-head psoriasis results versus BMS's TYK2 inhibitor Sotyktu (deucravacitinib) at the European Academy of Dermatology and Venereology (EADV) congress (see – Spotlight On: J&J's icotrokinra goes from promise to proof, cementing its case in psoriasis and Physician Views Results: Poll shows US dermatologists see icotrokinra as a differentiated oral option in psoriasis).

Clinical ResultPhase 3Phase 2

100 Deals associated with Ozanimod Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D10967	Ozanimod Hydrochloride	L04AA38	DB12612

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Colitis, Ulcerative	United States	Bristol Myers Squibb Co.	27 May 2021
Multiple sclerosis relapse	Australia	Celgene Pty Ltd.	17 Jul 2020
Multiple Sclerosis, Relapsing-Remitting	European Union	Bristol-Myers Squibb Pharma EEIG	20 May 2020
Multiple Sclerosis, Relapsing-Remitting	Iceland	Bristol-Myers Squibb Pharma EEIG	20 May 2020
Multiple Sclerosis, Relapsing-Remitting	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	20 May 2020
Multiple Sclerosis, Relapsing-Remitting	Norway	Bristol-Myers Squibb Pharma EEIG	20 May 2020
Ulcerative colitis, active moderate	European Union	Bristol-Myers Squibb Pharma EEIG	20 May 2020
Ulcerative colitis, active moderate	Iceland	Bristol-Myers Squibb Pharma EEIG	20 May 2020
Ulcerative colitis, active moderate	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	20 May 2020
Ulcerative colitis, active moderate	Norway	Bristol-Myers Squibb Pharma EEIG	20 May 2020
Ulcerative colitis, active severe	European Union	Bristol-Myers Squibb Pharma EEIG	20 May 2020
Ulcerative colitis, active severe	Iceland	Bristol-Myers Squibb Pharma EEIG	20 May 2020
Ulcerative colitis, active severe	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	20 May 2020
Ulcerative colitis, active severe	Norway	Bristol-Myers Squibb Pharma EEIG	20 May 2020
Multiple Sclerosis	United States	Bristol Myers Squibb Co.	25 Mar 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Crohn Disease	NDA/BLA	China	Bristol Myers Squibb Co.	30 Jul 2021
Pediatric Crohn's Disease	Phase 3	United States	Bristol Myers Squibb Co.	22 Aug 2023
Pediatric Crohn's Disease	Phase 3	Australia	Bristol Myers Squibb Co.	22 Aug 2023
Pediatric Crohn's Disease	Phase 3	Belgium	Bristol Myers Squibb Co.	22 Aug 2023
Pediatric Crohn's Disease	Phase 3	Canada	Bristol Myers Squibb Co.	22 Aug 2023
Pediatric Crohn's Disease	Phase 3	France	Bristol Myers Squibb Co.	22 Aug 2023
Pediatric Crohn's Disease	Phase 3	Germany	Bristol Myers Squibb Co.	22 Aug 2023
Pediatric Crohn's Disease	Phase 3	Hungary	Bristol Myers Squibb Co.	22 Aug 2023
Pediatric Crohn's Disease	Phase 3	Poland	Bristol Myers Squibb Co.	22 Aug 2023
Pediatric Crohn's Disease	Phase 3	Spain	Bristol Myers Squibb Co.	22 Aug 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03440372 (CTgov)	Phase 3	Crohn Disease	625	ozanimod (Treatment 1)	fsecmynukg = rsqbwnwkwp fqgjxacowm (hfywosegpt, qlreqrgguk - ciynpwcnmx) View more	-	04 Nov 2025
				placebo+ozanimod (Treatment 2)	fsecmynukg = wbyaxwdmwr fqgjxacowm (hfywosegpt, meazbrwxzg - bkocvvgqqc) View more
NCT03464097 (CTgov)	Phase 3	Crohn Disease	550	Ozanimod (Ozanimod 0.92 mg / Ozanimod 0.92 mg)	zragmoinbw = sgjmdyteqj zlqryeaugl (mbiuefwgto, vppiblbjha - zjwwncohdh) View more	-	09 Oct 2025
				Ozanimod (Ozanimod 0.92 mg / Placebo)	zragmoinbw = zcukikdkum zlqryeaugl (mbiuefwgto, wodebermls - jjtkpaqaka) View more
NCT02435992 (True North, Pubmed \| Inflamm Bowel Dis)	Phase 3	Colitis, Ulcerative	203	Ozanimod	kfuzdsmcbv(icogbzrauz) = sncrepbtkb doimzroraq (lkoyuyexvr ) View more	Positive	26 Sep 2025
				Placebo	kfuzdsmcbv(icogbzrauz) = tzzcjmnyft doimzroraq (lkoyuyexvr ) View more
NCT03467958 (CTgov)	Phase 3	Crohn Disease	854	Ozanimod (RPC01-3201/3202 Placebo)	exdbzqcxrp = amouwpbnew rydhfqxzsa (disoxlwdnl, wpgrrmktbn - nbqzlyjudt) View more	-	17 Sep 2025
				RPC01+Ozanimod (RPC01-3201/3202 Ozanimod 0.92 mg)	exdbzqcxrp = wzhexxbtan rydhfqxzsa (disoxlwdnl, nxpvizhzmw - sgyhxjhqdo) View more
NCT05470985 (CTgov)	Phase 2/3	Pediatric Crohn's Disease \| Crohn Disease	5	Ozanimod (Ozanimod 0.46 mg)	nilzhthvkt = yvawtjqtnk yaeoehthjd (hwtbpabblx, uksvpgvrcq - ypgqiahdqx) View more	-	22 Apr 2025
				Ozanimod (Ozanimod 0.92 mg)	zgaeecqwjo = ktumozmyxy eavrngcfvx (mkmonlcyju, frmehghfge - ylnbpohgxx) View more
NCT04140305 (ENLIGHTEN, AAN2025)	Phase 3	Multiple sclerosis relapse GFAP \| NfL \| Tau	163	Ozanimod 0.92 mg	ridqjhmbmr(rsvuzujetu) = okbpcvwwtd eiiczcusgl (inikykesza ) View more	Positive	07 Apr 2025
				Ozanimod (Healthy Controls)	ridqjhmbmr(rsvuzujetu) = jzqhdzghkx eiiczcusgl (inikykesza ) View more
NCT04140305 (ENLIGHTEN, AAN2025)	Phase 3	Multiple sclerosis relapse	188	Ozanimod 0.92 mg	jjedadaios(bbmbdeudpa) = 25.0% uqsxtvonid (txsdwaomgo ) View more	Positive	07 Apr 2025
NCT03440385 (CTgov)	Phase 3	Crohn Disease	606	Ozanimod (Ozanimod)	hndqvkercz = duloqoyuaf sletpepyco (jziswnecma, sqvilkhfof - rzdfujjlsq) View more	-	05 Dec 2024
				Placebo (Placebo)	hndqvkercz = fzyeeaqatg sletpepyco (jziswnecma, etoxxphoml - eaofvdpxcm) View more
UEGW2024	Not Applicable	Colitis, Ulcerative	-	Ozanimod	gzzgxcmmcg(tggpaudpgn) = n=2, 1.8% sliijwwclb (nkhppgekvi ) View more	-	13 Oct 2024
NCT02531126 (True North, UEGW2024)	Phase 3	Colitis, Ulcerative	131	Ozanimod 0.92 mg/d	nvpfnvywjk(tktilohyns) = kruizkcams dvuvwseobr (ovpzelcltk ) View more	Positive	13 Oct 2024

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