Clinical Trials

Numerous Phase 1 through Phase 4 clinical trials evaluate ozanimod hydrochloride across relapsing multiple sclerosis, ulcerative colitis, Crohn's disease, COVID-19, and healthy volunteer cohorts. Supported by major industry sponsors like Bristol-Myers Squibb and Celgene alongside academic medical centers including Johns Hopkins University and the University of Colorado, Denver, these studies encompass completed, active, recruiting, and terminated statuses. Together, these evaluations demonstrate extensive research into the safety, long-term efficacy, and real-world outcomes of ozanimod hydrochloride.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05076175 RECRUITING
Colitis, Ulcerative
Bristol-Myers Squibb
 2022-05-30 PHASE2; PHASE3
NCT06408259 RECRUITING
Multiple Sclerosis, Relapsing-Remitting
Bristol-Myers Squibb
 2025-04-08 PHASE3
NCT06396039 ACTIVE_NOT_RECRUITING
Relapsing Multiple Sclerosis
Bristol-Myers Squibb
 2024-05-15 PHASE4
NCT06529406 RECRUITING
Relapsing Multiple Sclerosis
University of Colorado, Denver
 2024-07-29 PHASE4
NCT06334094 WITHDRAWN
Multiple Sclerosis
The University of Texas at Dallas
 2024-06-01 PHASE4
NCT06862960 RECRUITING
Alzheimer Disease
ChenXiaoChun
 2025-08-13 PHASE2
NCT06181630 WITHDRAWN
Lactating Women; Breastfed Infants
Bristol-Myers Squibb
 2025-11-15 PHASE4
NCT03500328 ACTIVE_NOT_RECRUITING
Multiple Sclerosis, Relapsing-Remitting
Johns Hopkins University
 2018-05-02
NCT06188637 WITHDRAWN
Ulcerative Colitis
Geert D'Haens
 2024-08-01 PHASE4
NCT03915769 COMPLETED
Colitis, Ulcerative
Celgene
 2019-06-03 PHASE3
NCT04140305 TERMINATED
Multiple Sclerosis
Celgene
 2020-01-16 PHASE3
NCT05644665 TERMINATED
Ulcerative Colitis
Bristol-Myers Squibb
 2022-12-09 PHASE3
NCT05369832 TERMINATED
Colitis, Ulcerative
Bristol-Myers Squibb
 2022-12-16 PHASE4
NCT03467958 TERMINATED
Crohn Disease
Celgene
 2018-08-24 PHASE3
NCT03464097 TERMINATED
Crohn Disease
Celgene
 2018-06-27 PHASE3
NCT03440372 TERMINATED
Crohn Disease
Celgene
 2018-02-27 PHASE3
NCT05470985 TERMINATED
Crohn Disease
Bristol-Myers Squibb
 2023-08-22 PHASE2; PHASE3
NCT05777902 TERMINATED
Multiple Sclerosis
I.R.C.C.S. Fondazione Santa Lucia
 2023-01-31 PHASE4
NCT03440385 COMPLETED
Crohn Disease
Celgene
 2018-03-07 PHASE3
NCT05028634 COMPLETED
Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Celgene
 2021-11-11 PHASE3
NCT04978298 COMPLETED
Healthy Volunteers
Celgene
 2021-07-19 PHASE1
NCT04639115 COMPLETED
Liver Diseases; Digestive System Diseases
Celgene
 2020-12-18 PHASE1
NCT04405102 TERMINATED
COVID-19
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
 2020-09-16 PHASE2
NCT05001152 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2021-09-09 PHASE1
NCT04528290 COMPLETED
Healthy Volunteers
Celgene
 2020-10-07 PHASE1
NCT04211558 COMPLETED
Healthy Volunteer
Celgene
 2020-08-12 PHASE1
NCT04149678 COMPLETED
Healthy Volunteers
Celgene
 2019-10-04 PHASE1
NCT03694119 COMPLETED
Healthy Volunteer
Celgene
 2018-07-24 PHASE1
NCT03644576 COMPLETED
Healthy Volunteers
Celgene
 2018-07-11 PHASE1
NCT03624959 COMPLETED
Healthy Volunteer
Celgene
 2018-06-20 PHASE1
NCT02047734 COMPLETED
Relapsing Multiple Sclerosis
Celgene
 2013-12-03 PHASE3
NCT02294058 COMPLETED
Multiple Sclerosis
Celgene
 2014-12-03 PHASE3
NCT01647516 COMPLETED
Ulcerative Colitis
Celgene
 2012-12-26 PHASE2
NCT01628393 COMPLETED
Relapsing Multiple Sclerosis
Celgene
 2012-09-18 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-07-23)

Check the Ozanimod hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ozanimod hydrochloride selectively binds to and activates sphingosine 1-phosphate receptor subtypes 1 (S1P1) and 5 (S1P5), triggering receptor internalization and degradation that prevents lymphocyte egress from secondary lymphoid organs into central circulation. By reducing circulating autoreactive lymphocytes, this target modulation halts pathologic lymphocyte infiltration into target tissue, mitigating chronic inflammatory damage in clinical conditions such as relapsing multiple sclerosis and ulcerative colitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.