Wednesday, July 8, 2026

Drug profile · INN

siponimod

siponimod (MAYZENT) is a sphingosine 1-phosphate receptor edg-1 agonist. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L04) L04
US status approved
Patents linked 1
Pipeline programs 3
News articles 0
Drug details — siponimod
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
ORAL
Patents
1
Programs
3
Data quality
0.84

Quick answer

siponimod (MAYZENT) is a sphingosine 1-phosphate receptor edg-1 agonist. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN siponimod
Brand MAYZENT
Mechanism Sphingosine 1-phosphate receptor Edg-1 agonist
Target Sphingosine 1-phosphate receptor 1
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route ORAL
Formulation TABLET
ATC code L04

Mechanism of action

Sphingosine 1-phosphate receptor Edg-1 agonist

Primary target: Sphingosine 1-phosphate receptor 1

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. CBAF312D2301 Phase 3 · Novartis India · Multiple Sclerosis in pediatric patients
  2. GR-2021-12373041 Approved · Théa Pharma Ireland · patients with secondary progressive MS
  3. SIPO20 Approved · Théa Pharma Ireland · Active progressive multiple sclerosis course after an initia

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 11673860

    Crystalline siponimod fumaric acid and polymorphs thereof

    Expires Mon Jun 08 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is siponimod?

siponimod (MAYZENT) is a sphingosine 1-phosphate receptor edg-1 agonist. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for siponimod?

MAYZENT is a marketed brand name for siponimod. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of siponimod?

siponimod has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.