Wednesday, July 8, 2026

Drug profile · INN

leflunomide

leflunomide (APO-LEFLUNOMIDE) 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 Antineoplastic and immunomodulating agents (L04) L04AK01
US status approved
Patents linked 3
Pipeline programs 10
News articles 0
Drug details — leflunomide
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
ORAL
Patents
3
Programs
10
Data quality
0.89

Quick answer

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

Key facts

INN leflunomide
Brand APO-LEFLUNOMIDE
Mechanism Dihydroorotate dehydrogenase inhibitor
Target Dihydroorotate dehydrogenase (quinone), mitochondrial
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route ORAL
Formulation TABLET
ATC code L04AK01

Mechanism of action

Dihydroorotate dehydrogenase inhibitor

Primary target: Dihydroorotate dehydrogenase (quinone), mitochondrial

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. C0251010 Phase 3 · First Biotech (Australia) · Idiopathic Inflammatory Myopathy (including dermatomyositis
  2. Leflunomide Mylan for polymyalgia rheumatica Phase 3 · Disc Medicine · polymyalgia rheumatica
  3. APHP190131 Phase 2 · PARItec · Primary Sjogren's syndrome
  4. Leflunomide Phase 2 · Sanofi Pasteur MSD · Systemic Lupus Eythematosus (SLE)
  5. Leflunomide CF for primary Sjögren's Syndrome Phase 2 · Disc Medicine · primary Sjögren's Syndrome
  6. ARAVA® 20 mg tablets Phase 1 · Teva Pharma · Healthy
  7. Leflunomide 20 mg Tablets Phase 1 · Teva Pharma · Healthy
  8. NORD-STAR Approved · George Institute for · Rheumatoid Arthritis

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 6806373

    Process for preparing leflunomide form I

    Expires Mon Oct 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired
  2. US 6723855

    Method for synthesizing leflunomide

    Expires Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired
  3. US 6610718

    Processes for making- and a new crystalline form of- leflunomide

    Expires Mon Aug 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is leflunomide?

leflunomide (APO-LEFLUNOMIDE) 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 leflunomide?

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

What is the US approval status of leflunomide?

leflunomide 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.