Zeposia

(Ozanimod)

ApprovedSmall molecule

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Zeposia is a small molecule that works as a S1P1/5 Receptor Modulator.[2] It is being used across 7 indications, with its most advanced program in Approved.[1]

Zeposia is one of 214 small molecule programs targeting Alzheimer disease. It is currently in Approved.

Indications

Total Trials

Active Trials

213

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Alzheimer DiseaseRecruiting

Relapsing-Remitting Multiple SclerosisApproved

Non-Small Cell Lung CancerApproved

Ulcerative ColitisTerminated

Multiple SclerosisTerminated

ProspectiveRecruiting

Colitis, UlcerativeRecruiting

Alzheimer DiseasePhase 2

Recruiting

Relapsing-Remitting Multiple SclerosisApproved

Approved

Non-Small Cell Lung CancerApproved

Approved

Ulcerative ColitisApproved

Terminated

Multiple SclerosisApproved

Terminated

ProspectiveApproved

Recruiting

Colitis, UlcerativePreclinical

Recruiting

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Zeposia

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

42 2

Taxol

Verzenio

7 4

SKB264

SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Phase 3

5 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 10

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Alzheimer Disease

NCT06862960

Recruiting

Ulcerative Colitis

NCT07271069

Q2 2028

Recruiting

ESS

NCT06073873

Q3 2029

Post-ApprovalRecruiting

Prospective

NCT06529406

Q1 2031

Active, not recruiting

Multiple Sclerosis

NCT05688436

Clinical

Trials by Indication[1]

Ulcerative Colitis10 trials

Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success

Unknown status·IInsel Gruppe AG, University Hospital Bern··NCT05702879·240 enrolled

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT07271069·150 enrolled

Define Predictors of Response to Ozanimod in UC Discovering Biomarkers in the Management of Ulcerative Colitis

Withdrawn·—··NCT05809583

Show 7 more trials

A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06126835·2,828 enrolled

A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT05644665·131 enrolled

A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT05382715·175 enrolled

To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03915769·198 enrolled

An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT05369832·139 enrolled

Ulcerative Colitis Leukocyte TRAfficking After Treatment With Zeposia: the ULTRAZ Study

Withdrawn·GGeert D'Haens·Phase 4·NCT06188637

Efficacy and Safety Study of Ozanimod in Ulcerative Colitis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01647516·199 enrolled

Multiple Sclerosis8 trials

A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06133049·2,961 enrolled

Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02047734·1,320 enrolled

Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02294058·1,346 enrolled

Show 5 more trials

Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients

Terminated·—··NCT05319093·26 enrolled

Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2/3·NCT01628393·258 enrolled

Multidimensional Integrated Assessment to Test the Efficacy and Response to Ozanimod in Multiple Sclerosis.

Terminated·II.R.C.C.S. Fondazione Santa Lucia·Phase 4·NCT05777902·30 enrolled

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Active, not recruiting· Biogen logo

Biogen··NCT05688436·1,178 enrolled

Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT07732907·15 enrolled

Interaction3 trials

Drug Interaction Study of the Effect on Cyclosporine on Ozanimod and Major Active Metabolites

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04149678·40 enrolled

Drug-drug Interaction Study of Ozanimod With Inhibitor or Inducer of CYP2C8 and/or CYP3A

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03624959·100 enrolled

Drug-drug Interaction Study of Ozanimod With Tyramine to Evaluate the Effect on Pressor Response

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03694119·92 enrolled

Induction Therapy2 trials

Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03440372·625 enrolled

Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03440385·606 enrolled

ESS2 trials

Taste Assessment of Ozanimod

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05001152·7 enrolled

A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06073873·3,000 enrolled

16 more indications

Crohn's Disease2 trials

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2/3·NCT05470985·5 enrolled

An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03467958·854 enrolled

Blood Pressure1 trial

Drug-drug Interaction Study of Ozanimod With Pseudoephedrine to Evaluate the Effect on Blood Pressure and Heart Rate

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03644576·54 enrolled

Maintenance Therapy1 trial

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT03464097·550 enrolled

Moderate Hepatic Impairment1 trial

A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild or Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Ozanimod

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04639115·26 enrolled

Tics1 trial

Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT03665610·212 enrolled

COVID-191 trial

COVID-19 Ozanimod Intervention Study

Terminated·CCentre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec·Phase 2·NCT04405102·43 enrolled

Prospective1 trial

Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod

Recruiting·UUniversity of Colorado, Denver·Phase 4·NCT06529406·100 enrolled

Treatment1 trial

Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04978298·128 enrolled

Relapsing-Remitting Multiple Sclerosis1 trial

A Study Investigating the Utilization, Effectiveness and Quality of Life in Clinical Practice in Germany for Participants With Relapsing-remitting Multiple Sclerosis Treated With Ozanimod (Zeposia®)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT05335031·450 enrolled

Biomarkers1 trial

Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS

Withdrawn·—·Phase 4·NCT06334094

Oral1 trial

Relationship Between Oral DMT Burden and Adherence in MS

Enrolling by invitation·MMonash University··NCT04676204·323 enrolled

Adult Subject1 trial

A Study to Evaluate the Relative Bioavailability of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04528290·56 enrolled

Adult1 trial

A Study to Evaluate the Pharmacokinetics of Single Oral Doses of Ozanimod in Healthy Adult Chinese Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04211558·24 enrolled

Colitis, Ulcerative1 trial

A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Preclinical·NCT05076175·120 enrolled

Multiple Sclerosis, Relapsing-Remitting1 trial

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

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06408259·194 enrolled

Alzheimer disease1 trial

Ozanimod for the Treatment of Alzheimer's Disease: a Proof-of-concept Study

Recruiting·CChenXiaoChun·Phase 2·NCT06862960·40 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 25, 2020

ZEPOSIA

NDA NDA209899

Mar 25, 2020

ZEPOSIA

NDA NDA209899

Dec 15, 2021

ZEPOSIA

NDA NDA209899

Sep 29, 2022

ZEPOSIA

NDA NDA209899

Aug 10, 2023

ZEPOSIA

NDA NDA209899

Aug 10, 2023

ZEPOSIA

NDA NDA209899

Jun 5, 2024

ZEPOSIA

NDA NDA209899

Jun 5, 2024

ZEPOSIA

NDA NDA209899

Aug 30, 2024

ZEPOSIA

NDA NDA209899

Aug 30, 2024

ZEPOSIA

NDA NDA209899

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Ozanimod. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ozanimod compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ozanimod. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209899). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Zeposia. U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Ozanimod. U.S. National Library of Medicine.
[7]
SEC EDGAR — Karuna Therapeutics, Inc., a Bristol Myers Squibb company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: S1P1/5 Receptor Modulator[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Patent Landscape[5]

Patent Cliff

May 14, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9382217May 14, 2029

8796318May 14, 2029

10239846Nov 15, 2030

8481573Mar 24, 2033

11680050Sep 30, 2038

Key Publications[6]

Ozanimod in Moderately to Severely Active Ulcerative Colitis: TRUE NORTH

N Engl J MedJan 6, 2022DOI: 10.1056/NEJMoa2104177

Zeposia

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q2 2028

Q3 2029

Q1 2031

Trials by Indication[1]

Ulcerative Colitis10 trials

Multiple Sclerosis8 trials

Interaction3 trials

Induction Therapy2 trials

ESS2 trials

Crohn's Disease2 trials

Blood Pressure1 trial

Maintenance Therapy1 trial

Moderate Hepatic Impairment1 trial

Tics1 trial

COVID-191 trial

Prospective1 trial

Treatment1 trial

Relapsing-Remitting Multiple Sclerosis1 trial

Biomarkers1 trial

Oral1 trial

Adult Subject1 trial

Adult1 trial

Colitis, Ulcerative1 trial

Multiple Sclerosis, Relapsing-Remitting1 trial

Alzheimer disease1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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