Wednesday, July 8, 2026

Drug profile · INN

teriflunomide

teriflunomide (APO-TERIFLUNOMIDE) is a dihydroorotate dehydrogenase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L04) L04AK02
US status approved
Patents linked 0
Pipeline programs 9
News articles 0
Drug details — teriflunomide
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
ORAL
Patents
0
Programs
9
Data quality
0.89

Quick answer

teriflunomide (APO-TERIFLUNOMIDE) is a dihydroorotate dehydrogenase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN teriflunomide
Brand APO-TERIFLUNOMIDE
Mechanism Dihydroorotate dehydrogenase inhibitor
Target Dihydroorotate dehydrogenase (quinone), mitochondrial
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route ORAL
Formulation TABLET
ATC code L04AK02

Mechanism of action

Dihydroorotate dehydrogenase inhibitor

Primary target: Dihydroorotate dehydrogenase (quinone), mitochondrial

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. CLOU064C12301 Phase 3 · Novartis India · Multiple Sclerosis
  2. CLOU064C12302 Phase 3 · Novartis India · Multiple Sclerosis
  3. COMB157G3301 Phase 3 · Novartis India · relapsing multiple sclerosis (RMS)
  4. EFC17919A Phase 3 · Sanofi-Aventis U.S · multiple sclerosis
  5. EFC17919B Phase 3 · Sanofi-Aventis U.S · multiple sclerosis
  6. LTS17043 Phase 3 · Sanofi-Aventis U.S · Nervous system diseases
  7. LTS17043 Phase 3 · Sanofi-Aventis U.S · Nervous system diseases
  8. Teriflunomide Phase 3 · Merck KGaA, Darmstadt · Relapsing Multiple Sclerosis

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)

Frequently asked questions

What is teriflunomide?

teriflunomide (APO-TERIFLUNOMIDE) is a dihydroorotate dehydrogenase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for teriflunomide?

APO-TERIFLUNOMIDE is a marketed brand name for teriflunomide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of teriflunomide?

teriflunomide 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.