Wednesday, July 8, 2026

Drug profile · INN

capecitabine

capecitabine (CAPECITABINE SANDOZ) is a thymidylate synthase 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 (L01) L01BC06
US status approved
Patents linked 2
Pipeline programs 105
News articles 1
Drug details — capecitabine
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
2
Programs
105
Data quality
0.89

Quick answer

capecitabine (CAPECITABINE SANDOZ) is a thymidylate synthase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN capecitabine
Brand CAPECITABINE SANDOZ
Mechanism Thymidylate synthase inhibitor
Target DNA
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01BC06

Mechanism of action

Thymidylate synthase inhibitor

Primary target: DNA

Approval history

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

Recent coverage

Pipeline programs

  1. 20210098 Phase 3 · Amgen · Gastric and Gastroesophageal Junction Cancer With FGFR2b Ove
  2. 8951-CL-0305 Phase 3 · Astellas Pharma · Gastroesophageal Junction Adenocarcinoma, Gastric Cancer, Ga
  3. BOOG 2010-02 Stop&Go study Phase 3 · Teva Pharma · Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  4. C4221015 Phase 3 · First Biotech (Australia) · Colorectal cancer (BRAF V600E-mutant mCRC)
  5. CA244-0008 Phase 3 · Bristol-Myers Squibb Australia · Breast cancer, Triple-negative breast cancer
  6. CA2660003 Phase 3 · Bristol-Myers Squibb Australia · Untreated, Unresectable or Metastatic Colorectal Cancer
  7. CA2660004 Phase 3 · Bristol-Myers Squibb Australia · Previously Untreated Advanced or Metastatic Gastric, Gastroe
  8. CAPECITABINE Phase 3 · Disc Medicine · Salivary Duct Carcinoma

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. acyclovir Human herpesvirus 1 DNA polymerase inhibitor
  3. acyclovir sodium Human herpesvirus 1 DNA polymerase inhibitor
  4. anagrelide Antineoplastic and immunomodulating agents (L01)
  5. apremilast Antineoplastic and immunomodulating agents (L04)
  6. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  1. US 12285485

    Methods of treating pain

    Expires Mon Apr 24 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12016867

    Methods of treating inflammation and/or pain

    Expires Mon Jun 20 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is capecitabine?

capecitabine (CAPECITABINE SANDOZ) is a thymidylate synthase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for capecitabine?

CAPECITABINE SANDOZ is a marketed brand name for capecitabine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of capecitabine?

capecitabine 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.