Wednesday, July 8, 2026

Drug profile · INN

fingolimod hydrochloride

fingolimod hydrochloride (FINGOLIMOD HYDROCHLORIDE) is a sphingosine 1-phosphate receptor agonist. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 3
News articles 0
Drug details — fingolimod hydrochloride
US status
approved
Class
Route
ORAL
Patents
0
Programs
3
Data quality
0.89

Quick answer

fingolimod hydrochloride (FINGOLIMOD HYDROCHLORIDE) is a sphingosine 1-phosphate receptor agonist. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN fingolimod hydrochloride
Brand FINGOLIMOD HYDROCHLORIDE
Mechanism Sphingosine 1-phosphate receptor agonist
Target Sphingosine 1-phosphate receptor
Route ORAL
Formulation CAPSULE

Mechanism of action

Sphingosine 1-phosphate receptor agonist

Primary target: Sphingosine 1-phosphate receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. CBAF312D2301 Phase 3 · Novartis India · Multiple Sclerosis in pediatric patients
  2. CFTY720D2311 Phase 3 · Novartis India · Multiple Sclerosis
  3. WN42086 Phase 3 · HOFFMANN-LA ROCHE · Relapsing-Remitting Multiple Sclerosis

Related & competitor drugs

  1. fingolimod lauryl sulfate Sphingosine 1-phosphate receptor binding agent
  2. ponesimod Antineoplastic and immunomodulating agents (L04)
  3. etrasimod arginine Sphingosine 1-phosphate receptor Edg-6 modulator
  4. ozanimod hydrochloride Sphingosine 1-phosphate receptor Edg-1 modulator
  5. siponimod Antineoplastic and immunomodulating agents (L04)
  6. etrasimod Antineoplastic and immunomodulating agents (L04)

Frequently asked questions

What is fingolimod hydrochloride?

fingolimod hydrochloride (FINGOLIMOD HYDROCHLORIDE) is a sphingosine 1-phosphate receptor agonist. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for fingolimod hydrochloride?

FINGOLIMOD HYDROCHLORIDE is a marketed brand name for fingolimod hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of fingolimod hydrochloride?

fingolimod hydrochloride 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.