Wednesday, July 8, 2026

Drug profile · INN

mitomycin

mitomycin (MITOMYCIN) is a dna inhibitor. Route of administration: topical. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 4
Pipeline programs 16
News articles 0
Drug details — mitomycin
US status
approved
Class
Route
TOPICAL
Patents
4
Programs
16
Data quality
0.84

Quick answer

mitomycin (MITOMYCIN) is a dna inhibitor. Route of administration: topical. Current US regulatory status: approved.

Key facts

INN mitomycin
Brand MITOMYCIN
Mechanism DNA inhibitor
Target DNA
Route TOPICAL
Formulation INJECTABLE

Mechanism of action

DNA inhibitor

Primary target: DNA

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. 17000139BLC3004 Phase 3 · Janssen-Cilag International N.V · High-Risk Non-muscle-invasive Bladder Cancer
  2. 42756493BLC3004 Phase 3 · Janssen-Cilag International N.V · FGFR+ Intermediate-risk Non-muscle Invasive Bladder Cancer
  3. 42756493BLC3005 Phase 3 · Janssen-Cilag International N.V · High-risk Non-muscle-invasive Bladder Cancer with Susceptibl
  4. ISRCTN12053408 Phase 3 · Ningbo Cancer Hospital · Intermediate stage Hepatocellular carcinoma
  5. Mitomycin-C Phase 3 · United Therapeutics Europe · Corneal Opacity
  6. PRODIGE85-KANALRAD Phase 3 · CERo Therapeutics · locally advanced anal squamous cell carcinoma
  7. UGN-102 (Mitomycin) Phase 3 · Anaxis Pharma · Non-Muscle Invasive Bladder Cancer
  8. UGN-103 (Mitomycin) Phase 3 · Anaxis Pharma · Nonmuscle Invasive Bladder Cancer

Related & competitor drugs

  1. acyclovir Human herpesvirus 1 DNA polymerase inhibitor
  2. acyclovir sodium Human herpesvirus 1 DNA polymerase inhibitor
  3. azacitidine Antineoplastic and immunomodulating agents (L01)
  4. bleomycin sulfate DNA inhibitor
  5. busulfan Antineoplastic and immunomodulating agents (L01)
  6. capecitabine Antineoplastic and immunomodulating agents (L01)

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    Expires Mon Jul 16 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

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Frequently asked questions

What is mitomycin?

mitomycin (MITOMYCIN) is a dna inhibitor. Route of administration: topical. Current US regulatory status: approved.

What is the brand name for mitomycin?

MITOMYCIN is a marketed brand name for mitomycin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of mitomycin?

mitomycin 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.