CLINICAL TRIALS PROFILE FOR ZEPOSIA

All Clinical Trials for ZEPOSIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05777902 ↗	Multidimensional Integrated Assessment to Test the Efficacy and Response to Ozanimod in Multiple Sclerosis.	Recruiting	I.R.C.C.S. Fondazione Santa Lucia	Phase 4	2023-01-31	This is a prospective interventional study with a 12-month follow-up of patients diagnosed with Multiple Sclerosis. Enrollment includes patients for whom Ozanimod will be prescribed based on regular clinical practice. It is proposed to integrate the measurements obtained using multiple instruments, with the aim of analyzing the immunological landscape, connectivity networks and anatomical traits of neurodegeneration. Patients will return for imaging and noninvasive electrophysiological studies 3, 6, and 12 months after initiation of therapy. On the same day, blood samples will be taken and immunological and biochemical tests will be performed.
NCT06188637 ↗	Ulcerative Colitis Leukocyte TRAfficking After Treatment With Zeposia: the ULTRAZ Study	Not yet recruiting	Bristol-Myers Squibb	Phase 4	2024-03-01	The ULTRAZ study is designed to better understand the mode of action of S1P receptor modulators. The alteration of leukocyte trafficking due to S1P receptors such as ozanimod is mainly investigated in rodent studies. Several previous studies show a reduced total leukocyte count in peripheral blood and only two study reported the effect of leukocyte subgroups before and after treatment with ozanimod. The change in leukocyte subgroups in peripheral blood as well as colonic mucosa and lymph nodes have not been investigated to our knowledge. Therefore, the aim of this study is to explore the changes in these three compartments.
NCT06188637 ↗	Ulcerative Colitis Leukocyte TRAfficking After Treatment With Zeposia: the ULTRAZ Study	Not yet recruiting	Geert D'Haens	Phase 4	2024-03-01	The ULTRAZ study is designed to better understand the mode of action of S1P receptor modulators. The alteration of leukocyte trafficking due to S1P receptors such as ozanimod is mainly investigated in rodent studies. Several previous studies show a reduced total leukocyte count in peripheral blood and only two study reported the effect of leukocyte subgroups before and after treatment with ozanimod. The change in leukocyte subgroups in peripheral blood as well as colonic mucosa and lymph nodes have not been investigated to our knowledge. Therefore, the aim of this study is to explore the changes in these three compartments.
NCT06529406 ↗	Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod	RECRUITING	University of Colorado, Denver	PHASE4	2024-07-29	A multi-center pilot study to evaluate safety and efficacy of ozanimod as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.

Clinical Trial Conditions for ZEPOSIA

Condition Name

Condition Name for ZEPOSIA
Intervention	Trials
Multiple Sclerosis	1
Relapsing Multiple Sclerosis	1
Ulcerative Colitis	1

Condition MeSH

Condition MeSH for ZEPOSIA
Intervention	Trials
Ulcer	1
Colitis, Ulcerative	1
Colitis	1
Sclerosis	1

Clinical Trial Locations for ZEPOSIA

Trials by Country

Trials by Country for ZEPOSIA
Location	Trials
United States	3
Italy	1

Trials by US State

Trials by US State for ZEPOSIA
Location	Trials
Ohio	1
Nevada	1
Colorado	1

Clinical Trial Progress for ZEPOSIA

Clinical Trial Phase

Clinical Trial Phase for ZEPOSIA
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	2

Clinical Trial Status

Clinical Trial Status for ZEPOSIA
Clinical Trial Phase	Trials
RECRUITING	2
Not yet recruiting	1

Clinical Trial Sponsors for ZEPOSIA

Sponsor Name

Sponsor Name for ZEPOSIA
Sponsor	Trials
University of Colorado, Denver	1
I.R.C.C.S. Fondazione Santa Lucia	1
Bristol-Myers Squibb	1

Sponsor Type

Sponsor Type for ZEPOSIA
Sponsor	Trials
Other	3
Industry	1

ZEPOSIA (Ozanimod) Clinical Trials Update, Market Analysis, and Projection

Last updated: May 4, 2026

What is ZEPOSIA and what is the current clinical development map?

ZEPOSIA (ozanimod) is an oral sphingosine-1-phosphate (S1P) receptor modulator approved for relapsing forms of multiple sclerosis (RMS) and for moderately to severely active ulcerative colitis (UC). The clinical development program spans confirmatory and expanding indications in RMS and UC, plus pipeline efforts in other immune-mediated diseases.

Key approved-use clinical context (anchors for trial interpretation)

• Multiple sclerosis (RMS): The pivotal program for RMS uses relapse-rate and disability outcomes; later studies and post-approval work track long-term safety and real-world effectiveness.
• Ulcerative colitis: The pivotal UC program uses clinical response and remission end points plus durability and safety.

Trial update status (publicly disclosed)

Across public sources, the most actionable near-to-mid-term “trial update” signals for ZEPOSIA typically come from:

• Regulatory submission milestones (label expansions, new cohorts, new disease areas).
• Conference disclosures (oral and poster results for ongoing Phase 2 and Phase 3 programs).
• Long-term extension safety reporting (especially for S1P-class class effects: cardiac conduction, macular edema risk, infection risk, liver enzyme elevations).

Because the user request requires a complete, accurate, trial-by-trial update, a fully defensible update must be grounded in specific trial identifiers (e.g., NCT numbers), dates, and endpoints. No such trial-specific dataset was provided in the prompt, and generating one without source-backed details would violate the requirement to be complete and accurate.

What is the market and competitive position for ZEPOSIA?

ZEPOSIA competes in two primary treatment landscapes:

• Multiple sclerosis (RMS): S1P modulators and other high-efficacy oral disease-modifying therapies (DMTs) dominate the market segment. ZEPOSIA’s differentiators typically revolve around dosing convenience, safety profile, and uptake driven by prescriber and payer preferences.
• Ulcerative colitis: The oral small-molecule and biologic ecosystems compete on induction speed, durability, safety, and formulary placement. ZEPOSIA’s market traction depends on how payers evaluate it against BTK inhibitors, JAK inhibitors, integrin antagonists, and anti-TNF and anti-IL-12/23 strategies.

Pricing and payer dynamics (how to think about revenue drivers)

ZEPOSIA’s near-term revenue is shaped by:

• Formulary access (commercial and Medicare Part D as applicable to the geography).
• Step therapy usage patterns in UC and RMS.
• Switching behavior from other S1P modulators and competing orals.
• Persistence and adherence (fixed oral dosing with monitoring requirements).

Competitive set (framework)

For RMS, ZEPOSIA is evaluated against other S1P modulators and oral high-efficacy DMTs that are already established in typical treatment pathways. For UC, it sits among oral immunomodulators and biologics competing on efficacy and tolerability tradeoffs.

What is the market projection for ZEPOSIA (base, bull, bear)?

A market projection for a specific drug needs:

• Market size by indication (RMS and UC),
• Share assumptions (current and target uptake),
• Pricing and discount assumptions,
• Persistence curves,
• Patent and exclusivity timelines,
• Competitive erosion (new entrants and label expansions by competitors),
• Geographic mix and reimbursement structure.

No quantitative inputs, market model parameters, geography scope, or time horizon were provided. Producing numerical projections without sourced base-case shares, penetration, and pricing assumptions would not satisfy “complete and accurate.”

What business milestones matter next for ZEPOSIA?

For decision-grade monitoring, the next value inflection points for ZEPOSIA generally fall into:

1. Readouts from ongoing trials that can support label expansions or new lines within UC and RMS.
2. Long-term safety update cycles, especially those that influence switching and payer confidence.
3. Real-world evidence that changes switching rates or adherence/persistence profiles.
4. Regulatory actions on new endpoints, post-marketing requirements, or label clarifications that affect utilization.

How should investors and R&D teams track progress?

A tight KPI set for ZEPOSIA’s trajectory in both RMS and UC typically includes:

• Prescription trajectory and new starts (indication-by-indication)
• Persistence at 6, 12, 18 months
• Share of switching from other high-efficacy orals
• Lab monitoring and treatment discontinuation rates related to safety events
• Payer policy changes (step edits, prior authorization strictness)

Key Takeaways

• ZEPOSIA (ozanimod) is an oral S1P modulator with established use in relapsing multiple sclerosis and ulcerative colitis, and its development path depends on additional trial readouts and long-term safety evidence cycles.
• Market outcomes are driven by formulary access, switching dynamics, and persistence in both RMS and UC.
• Producing a complete, accurate trial-by-trial “clinical trials update” and a numerical base/bull/bear market projection requires trial- and market-level inputs that are not present in the prompt.

FAQs

1. What indications does ZEPOSIA have?
   Relapsing forms of multiple sclerosis and moderately to severely active ulcerative colitis.

2. What is ZEPOSIA’s mechanism of action?
   It modulates S1P receptors, preventing lymphocyte trafficking to inflammatory sites.

3. What determines ZEPOSIA’s uptake in multiple sclerosis?
   High-efficacy oral treatment demand, payer formulary inclusion, and safety and monitoring acceptance.

4. What determines ZEPOSIA’s uptake in ulcerative colitis?
   Induction response, durability of remission, safety/tolerability, and competitive placement versus other oral immunomodulators and biologics.

5. What type of evidence most impacts ZEPOSIA’s next label or growth milestones?
   Clinical efficacy readouts, durability/safety updates, and regulatory outcomes that influence switching and payer confidence.

References

[1] FDA. ZEPOSIA (ozanimod) prescribing information.
[2] EMA. ZEPOSIA (ozanimod) product information.
[3] NCT ClinicalTrials.gov. ZEPOSIA (ozanimod) search results (trial listings and statuses).
[4] Published clinical trial articles for ozanimod in RMS and ulcerative colitis (primary efficacy and safety reports).