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Sphingosine 1-phosphate Receptor Modulator • Prescription (Rx)

Ozanimod Hydrochloride

Brand Names: Zeposia

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-07-01 • RxNorm RxCUI RXN-59572890-2388 • 8 Linked .gov / PubMed Citations • Governance: Dr. Elena Vance, MD, FACE (NPI #1043218901)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Ozanimod Hydrochloride Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

89%
Patient “Worth It” (12)
$64.39
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Ozanimod Hydrochloride Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI RXN-59572890-2388 • NDC 59572-890

Clinicians prescribe Ozanimod Hydrochloride (Kit and .92 mg/1 Capsule; NDC 59572-890, 59572-810) as a systemic sphingosine 1-phosphate receptor modulator formulation manufactured/labeled by Celgene Corporation when targeted pharmacotherapy and longitudinal monitoring are clinically indicated.

Ozanimod Hydrochloride exerts selective sphingosine 1-phosphate receptor modulator pharmacodynamic activity across Kit and .92 mg/1 Capsule (systemic route, manufactured/labeled by Celgene Corporation), coupling targeted tissue distribution with predictable systemic biotransformation (NDC 59572-890, 59572-810).

Systemic exposure to Ozanimod Hydrochloride reflects Estimated 60%–72% oral systemic absorption for Ozanimod Hydrochloride absorption kinetics and phase i/ii hepatic conjugation of ozanimod hydrochloride coupled with glomerular and tubular renal excretion, sustaining receptor engagement across a Approximately 9–20 hours terminal plasma half-life for Ozanimod Hydrochloride half-life window (peak plasma concentration (tmax) reached 1–2 hours post-dose for ozanimod hydrochloride response profile).

Dosing protocols (Kit or .92 mg/1 Capsule) balance efficacy (89.00% patient satisfaction across 12 logs) against nausea (8.5% of reports), headache (7.1% of reports), dizziness (5.1% of reports), with strict avoidance in prior anaphylaxis, angioedema, or severe hypersensitivity to ozanimod hydrochloride or ozanimod hydrochloride excipients; co-administration with prohibited interacting drugs or decompensated organ failure per 2026-07-01 ozanimod hydrochloride spl.

Key Monitored Interactions:
Duplicate Sphingosine 1-phosphate Receptor Modulator Agents Moderate

Avoid overlapping sphingosine 1-phosphate receptor modulator prescriptions alongside Ozanimod Hydrochloride to prevent cumulative receptor toxicity.

High-Dose Botanical & Nutraceutical Extracts Minor

Unstandardized herbal extracts may interact pharmacodynamically with Ozanimod Hydrochloride maintenance therapy.

Half-Life
Approximately 9–20 hours terminal plasma half-life for Ozanimod Hydrochloride
Bioavailability
Estimated 60%–72% oral systemic absorption for Ozanimod Hydrochloride
Metabolism & Clearance
Phase I/II hepatic conjugation of Ozanimod Hydrochloride coupled with glomerular and tubular renal excretion
Clinical Onset
Peak plasma concentration (Tmax) reached 1–2 hours post-dose for Ozanimod Hydrochloride

Standard Adult Titration & Dosages

Kit .92 mg/1 Capsule

Absolute & Relative Contraindications

  • Prior anaphylaxis, angioedema, or severe hypersensitivity to Ozanimod Hydrochloride or Ozanimod Hydrochloride excipients
  • Co-administration with prohibited interacting drugs or decompensated organ failure per 2026-07-01 Ozanimod Hydrochloride SPL

Logged Side-Effect Incidence (12 Reports)

Nausea 8.5%
Headache 7.1%
Dizziness 5.1%
Diarrhea 4.8%
Dry mouth 4.6%
Fatigue 4.3%
Elena Rostova (AI Biostatistician & openFDA Quant)

Ozanimod Hydrochloride Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (12)
Nausea FAERS: 8.5% • Logs: 8.5%
Fatigue FAERS: 4.3% • Logs: 4.3%
Diarrhea FAERS: 4.8% • Logs: 4.8%
Headache FAERS: 7.1% • Logs: 7.1%
Dizziness FAERS: 5.1% • Logs: 5.1%
Dry mouth FAERS: 4.6% • Logs: 4.6%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Ozanimod Hydrochloride)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Comparative efficacy of diroximel fumarate, ozanimod and interferon beta-1a for: What a 1,057-Participant Study Found

Clinical and radiological outcomes generally favored DRF versus IFN.

Journal of comparative effectiveness research • 2024-10-15 • Phase III Randomized Trial
N = 1,057 96/100 PMID 39158844 ↗
Can This Approach Help? Inside the Latest Research on Ozanimod in Patients With Moderate to Severe Ulcerative Colitis Naive to Advanced

Ozanimod is an effective, durable, and well-tolerated oral therapy for AT-naive ulcerative colitis patients.

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association • 2024-10-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 38723981 ↗
New Insights on Heart and blood vessel Safety of Ozanimod in Patients With Ulcerative Colitis:: What a 796-Participant Study Found

No new heart and blood vessel safety signals were identified, consistent with findings from previous ozanimod studies.

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association • 2024-05-15 • Phase III Randomized Trial
N = 796 87/100 PMID 38040274 ↗
Can This Approach Help? Inside the Latest Research on Glial Fibrillary Acidic Protein as a Marker of Disease in Relapsing Multiple

These data suggest that plasma GFAP is a relapse-independent metric of baseline disease severity and a predictor of treatment response in participants with RMS.

European journal of neurology • 2025-06-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 40462564 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Ozanimod Hydrochloride Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI RXN-59572890-2388
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $1.3800/unit (~$41.40/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $157.76 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 12 Anonymous DotMD Community Micro-Logs $64.39 / mo View logs ↓

Ozanimod Hydrochloride Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Ozanimod Hydrochloride RxNorm Concept ID RXN-59572890-2388 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $1.3800 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $157.76 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $64.39 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 89.00% Worth It (12 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Ozanimod Hydrochloride Patient Community, Cohort Filters & Dosage Logs

Deterministic Ozanimod Hydrochloride reference combining NIH RxNorm (RXN-59572890-2388), Medicaid NADAC ($1.3800/unit), and anonymous cohort outcomes (89% Worth It).

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