Wednesday, July 8, 2026

Drug profile · INN

mycophenolate mofetil

mycophenolate mofetil (CELLCEPT) is a inosine-5'-monophosphate dehydrogenase (impdh) inhibitor. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Antineoplastic and immunomodulating agents (L04) L04AA06
US status approved
Patents linked 1
Pipeline programs 71
News articles 0
Drug details — mycophenolate mofetil
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
ORAL
Patents
1
Programs
71
Data quality
0.89

Quick answer

mycophenolate mofetil (CELLCEPT) is a inosine-5'-monophosphate dehydrogenase (impdh) inhibitor. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN mycophenolate mofetil
Brand CELLCEPT
Mechanism Inosine-5'-monophosphate dehydrogenase (IMPDH) inhibitor
Target Inosine-5'-monophosphate dehydrogenase (IMPDH)
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route ORAL
Formulation FOR SUSPENSION
ATC code L04AA06

Mechanism of action

Inosine-5'-monophosphate dehydrogenase (IMPDH) inhibitor

Primary target: Inosine-5'-monophosphate dehydrogenase (IMPDH)

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. 20200041 Phase 3 · Amgen · Extensive stage small cell lung cancer (ES-SCLC)
  2. 20240178 Phase 3 · Amgen · Extensive stage small cell lung cancer (ES-SCLC).
  3. APHP200026 Phase 3 · PARItec · Patients with GPA and inadequate response to standard of car
  4. APHP200038 Phase 3 · PARItec · lupus nephritis
  5. C0251010 Phase 3 · First Biotech (Australia) · Idiopathic Inflammatory Myopathy (including dermatomyositis
  6. CA41705 Phase 3 · HOFFMANN-LA ROCHE · Lupus Nephritis (LN)
  7. CVAY736K12301 Phase 3 · Novartis India · Lupus nephritis
  8. CVAY736K12301E1 Phase 3 · Novartis India · Lupus nephritis

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 7358247

    Mycophenolate mofetil impurity

    Expires Mon Apr 10 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is mycophenolate mofetil?

mycophenolate mofetil (CELLCEPT) is a inosine-5'-monophosphate dehydrogenase (impdh) inhibitor. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for mycophenolate mofetil?

CELLCEPT is a marketed brand name for mycophenolate mofetil. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of mycophenolate mofetil?

mycophenolate mofetil 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.