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 6 indications, with its most advanced program in Approved.[1]

Zeposia is one of 180 small molecule programs targeting Relapsing-Remitting Multiple Sclerosis. It is currently in Approved.

Indications

Total Trials

Active Trials

179

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Relapsing-Remitting Multiple SclerosisApproved

Non-Small Cell Lung CancerApproved

Crohn's DiseaseActive, not recruiting

Ulcerative ColitisApproved

Multiple SclerosisActive, not recruiting

COVID-19Active, not recruiting

Relapsing-Remitting Multiple SclerosisApproved

Approved

Non-Small Cell Lung CancerApproved

Approved

Crohn's DiseasePhase 3

Active, not recruiting

Ulcerative ColitisApproved

Approved

Multiple SclerosisApproved

Active, not recruiting

COVID-19Phase 2

Active, not recruiting

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Zeposia

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

1 2

Spikevax

Moderna

Preclinical

21 3

Bnt162b2

BioNTech

Preclinical

29 4

Biaxin

AbbVie

Preclinical

2 5

Stivarga

Bayer

Preclinical

1 6

Aimovig

Amgen

Preclinical

1 7

Tricor

JJagotec

Preclinical

1 8

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 9

Low-Molecular-Weight Heparin

Daiichi Sankyo

Preclinical

3 10

SARS-COV-2 VACCINE

Moderna

Preclinical

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

Timeline

Expected Milestones

Q4 2027

Phase 2Not yet recruiting

Alzheimer's Disease

NCT06862960

Recruiting

Ulcerative Colitis

NCT07271069

Q2 2028

Recruiting

ESS

NCT06073873

Q3 2029

Post-ApprovalRecruiting

Prospective

NCT06529406

Q1 2031

Recruiting

Pregnancy

NCT05688436

Clinical

Trials by Indication[1]

Ulcerative Colitis11 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

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2/3·NCT05076175·120 enrolled

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT07271069·150 enrolled

Show 8 more trials

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

Efficacy and Safety Study of Ozanimod in Ulcerative Colitis

Completed· Bristol-Myers Squibb logo

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

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

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

Withdrawn·—··NCT05809583

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

Withdrawn·GGeert D'Haens·Phase 4·NCT06188637

Multiple Sclerosis7 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

Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

Recruiting· Bristol-Myers Squibb logo

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

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

Terminated·—··NCT05319093·26 enrolled

Show 4 more trials

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

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

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

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 Tyramine to Evaluate the Effect on Pressor Response

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03694119·92 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

Induction Therapy2 trials

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

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

ESS2 trials

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

Taste Assessment of Ozanimod

Completed· Bristol-Myers Squibb logo

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

15 more indications

Crohn's Disease2 trials

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

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

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

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

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

Pregnancy1 trial

A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies

Recruiting· Biogen logo

Biogen··NCT05688436·1,178 enrolled

Oral1 trial

Relationship Between Oral DMT Burden and Adherence in MS

Enrolling by invitation·MMonash University··NCT04676204·323 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

Alzheimer's Disease1 trial

Ozanimod in Patients With Alzheimer's Disease

Not yet recruiting·CChenXiaoChun·Phase 2·NCT06862960·40 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

Biomarkers1 trial

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

Withdrawn·—·Phase 4·NCT06334094

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

Regulatory

FDA Approval Timeline[4]

Mar 25, 2020

ZEPOSIA

NDA NDA209899

Sources

References

[1]
ClinicalTrials.gov — 41 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 Colitis11 trials

Multiple Sclerosis7 trials

Interaction3 trials

Induction Therapy2 trials

ESS2 trials

Crohn's Disease2 trials

Moderate Hepatic Impairment1 trial

Tics1 trial

Adult Subject1 trial

Adult1 trial

COVID-191 trial

Prospective1 trial

Treatment1 trial

Pregnancy1 trial

Oral1 trial

Maintenance Therapy1 trial

Alzheimer's Disease1 trial

Blood Pressure1 trial

Biomarkers1 trial

Relapsing-Remitting Multiple Sclerosis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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