Wednesday, July 8, 2026

Drug profile · INN

fingolimod

fingolimod (AKM FINGOLIMOD) is a sphingosine 1-phosphate receptor binding agent. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L04) L04AA27
US status approved
Patents linked 2
Pipeline programs 18
News articles 0
Drug details — fingolimod
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
ORAL
Patents
2
Programs
18
Data quality
0.84

Quick answer

fingolimod (AKM FINGOLIMOD) is a sphingosine 1-phosphate receptor binding agent. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN fingolimod
Brand AKM FINGOLIMOD
Mechanism Sphingosine 1-phosphate receptor binding agent
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route ORAL
Formulation CAPSULE
ATC code L04AA27

Mechanism of action

Sphingosine 1-phosphate receptor binding agent

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. Arm A Mylotarg plus DA Versus CPX-351 Phase 3 · Cardiff Oncology · Acute Myeloid Leukaemia
  2. CBAF312D2301 Phase 3 · Novartis India · Multiple Sclerosis in pediatric patients
  3. Fingolimod Phase 3 · Novartis India · Multiple Sclerosis (MS)
  4. IM047-050 Phase 3 · Bristol-Myers Squibb Australia · Relapsing Remitting Multiple Sclerosis
  5. TG1101-RMS-PED304 Phase 3 · TG THERAPEUTICS · Relapsing Multiple Sclerosis
  6. WN42086 Phase 3 · HOFFMANN-LA ROCHE · Relapsing-Remitting Multiple Sclerosis
  7. API-E004-CL-B4 Phase 2 · Amphastar France Pharmaceuticals · Asthma
  8. Arm 1: Standard Synchronous Group Phase 2 · First People's Hospital · Advanced Non-Small Cell Lung Cancer (NSCLC)

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 9186333

    Process for preparing pharmaceutical compositions of fingolimod

    Expires Mon Nov 12 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 8889627

    Treatment of multiple sclerosis with combination of laquinimod and fingolimod

    Expires Mon Nov 13 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is fingolimod?

fingolimod (AKM FINGOLIMOD) is a sphingosine 1-phosphate receptor binding agent. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for fingolimod?

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

What is the US approval status of fingolimod?

fingolimod 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.