Wednesday, July 8, 2026

Drug profile · INN

fluorouracil

fluorouracil (APOC-5FU) is a thymidylate synthase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

FDA: approved TGA: approved NMPA: clinical trials
US status approved
Patents linked 2
Pipeline programs 121
News articles 0
Drug details — fluorouracil
US status
approved
Class
Route
TOPICAL
Patents
2
Programs
121
Data quality
0.89

Quick answer

fluorouracil (APOC-5FU) is a thymidylate synthase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

Key facts

INN fluorouracil
Brand APOC-5FU
Mechanism Thymidylate synthase inhibitor
Target DNA
Route TOPICAL
Formulation INJECTABLE

Mechanism of action

Thymidylate synthase inhibitor

Primary target: DNA

Approval history

Authority Status Date
FDA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. 2020HXFH037 Phase 3 · Chinese Academy of · Nasopharyngeal Carcinoma
  2. 20210081 Phase 3 · Amgen · Colorectal Cancer (CRC)
  3. 20210096 Phase 3 · Amgen · Previously Untreated Advanced Gastric or Gastroesophageal Ju
  4. 20210098 Phase 3 · Amgen · Gastric and Gastroesophageal Junction Cancer With FGFR2b Ove
  5. 5-Fluorouracil Phase 3 · HOFFMANN-LA ROCHE · Breast Cancer
  6. 5-Fluoruracil Phase 3 · HOFFMANN-LA ROCHE · Gastric Cancer
  7. 61186372HNC3001 Phase 3 · Janssen-Cilag International N.V · Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous
  8. 8951-CL-0305 Phase 3 · Astellas Pharma · Gastroesophageal Junction Adenocarcinoma, Gastric Cancer, Ga

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)
  1. WO 2025090858

    PROCÉDÉS D'IDENTIFICATION DE VARIANTS DE CAPSIDE DE VAA AYANT DES CARACTÉRISTIQUES SOUHAITÉES

    Expires Wed Apr 26 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 9463193

    Individual 5-fluorouracile dose optimization in folfiri treatment

    Expires Mon Oct 06 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is fluorouracil?

fluorouracil (APOC-5FU) is a thymidylate synthase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: topical. Current US regulatory status: approved.

What is the brand name for fluorouracil?

APOC-5FU is a marketed brand name for fluorouracil. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of fluorouracil?

fluorouracil 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.