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ozanimod

Zeposia · ATC code L04AA38

Key facts
Active substance
ozanimod
Drug class
Immunosuppressive drug
ATC code
L04AA38
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Zeposia 0.23 mg hard capsules / Zeposia 0.46 mg hard capsules / Zeposia 0.92 mg hard capsules
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
Information as of
2026-10-28

Key facts

Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator. It is used in adults with relapsing remitting multiple sclerosis and with moderately to severely active ulcerative colitis.

What it is used for

  • Adults with relapsing remitting multiple sclerosis (RRMS) with active disease (Zeposia).
  • Adults with moderately to severely active ulcerative colitis who had an inadequate response, lost response or were intolerant to conventional therapy or a biologic.

Dosing

  • Dose escalation: days 1-4 0.23 mg, days 5-7 0.46 mg once daily; from day 8, 0.92 mg once daily, with or without food.
  • After interruptions (e.g. 1 day or more in the first 14 days, more than 7 days between day 15 and day 28, more than 14 days thereafter), restart the escalation regimen.
  • Mild or moderate hepatic impairment (Child-Pugh A or B): after escalation, 0.92 mg every other day; severe hepatic impairment: contraindicated.
  • No adjustment in renal impairment; caution in MS patients over 55 and UC patients over 65 years.

Contraindications

  • Hypersensitivity to the active substance or any excipient; immunodeficient state predisposing to opportunistic infections.
  • Myocardial infarction, unstable angina, stroke, TIA or decompensated heart failure in the last 6 months; NYHA Class III/IV heart failure.
  • Second-degree AV block Type II, third-degree AV block or sick sinus syndrome without a functioning pacemaker.
  • Severe active or active chronic infections (e.g. hepatitis, tuberculosis), active malignancies, severe hepatic impairment.
  • Pregnancy and women of childbearing potential not using effective contraception.

Important warnings

  • Transient reduction in heart rate at initiation: ECG before starting; caution with beta-blockers or calcium-channel blockers.
  • Infections including serious opportunistic infections and PML.
  • Liver injury, which may require liver transplantation; monitor liver tests.
  • Macular oedema and hypertension may occur.
  • Avoid live attenuated vaccines during and for up to 3 months after treatment.

Side effects

  • Most common: nasopharyngitis (12.3%), ALT increased (5%) and GGT increased (5.4%).
  • Transient bradycardia at initiation, usually resolving by the end of the first week.
  • Serious: opportunistic infections (including PML), macular oedema, hypertension, rare clinically significant liver injury.

Interactions

  • Anti-neoplastic, immunomodulatory or non-corticosteroid immunosuppressive therapies should not be co-administered.
  • MAO inhibitors (e.g. selegiline, phenelzine) are not recommended; CYP2C8 inducers such as rifampicin may reduce exposure.
  • Vaccines may be less effective during and for up to 3 months after treatment.

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; negative pregnancy test before starting and effective contraception during and for 3 months after treatment.
  • Breast-feeding: see the full text.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ZeposiaBristol-Myers Squibb Pharma EEIG · EMEA/H/C/004835

Source: European Medicines Agency (EMA), product information

Turkey

  • ZeposiaBRISTOL-MYERS SQUIBB İLAÇLARI INC. İSTANBUL ŞUBESİ · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Zeposia
Liechtenstein
Zeposia
Norway
Zeposia

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Zeposia – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/zeposia-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC L04AA.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.