Wednesday, July 8, 2026

Drug profile · INN

celecoxib

celecoxib (APX-CELECOXIB) is a cyclooxygenase-2 inhibitor. Associated with Viatris Pharmaceuticals Co.,. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: withdrawn TGA: approved Antineoplastic and immunomodulating agents (L01) L01XX33
US status approved
Patents linked 1
Pipeline programs 13
News articles 0
Drug details — celecoxib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
1
Programs
13
Data quality
0.89

Quick answer

celecoxib (APX-CELECOXIB) is a cyclooxygenase-2 inhibitor. Associated with Viatris Pharmaceuticals Co.,. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN celecoxib
Brand APX-CELECOXIB
Mechanism Cyclooxygenase-2 inhibitor
Target Prostaglandin G/H synthase 2
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation CAPSULE
ATC code L01XX33

Mechanism of action

Cyclooxygenase-2 inhibitor

Primary target: Prostaglandin G/H synthase 2

Approval history

Authority Status Date
FDA approved
EMA withdrawn
TGA approved

Pipeline programs

  1. Celecoxib Phase 3 · United Therapeutics Europe · Breast Cancer
  2. Celecoxib Phase 2 · Chinese Academy of · Oral Squamous Cell Carcinoma
  3. Celecoxib Phase 2 · United Therapeutics Europe · Head and Neck Cancer
  4. Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD) Phase 2 · Hospital Authority · Benign Prostatic Hyperplasia
  5. Fixed dose combination Ciprofloxacin/Celecoxib Phase 2 · NeuroSense Therapeutics · Amyotrophic Lateral Sclerosis
  6. Celecoxib Phase 1 · Akebia Europe · Healthy Volunteers
  7. Fixed dose combination Ciprofloxacin/Celecoxib Phase 1 · NeuroSense Therapeutics · ALS (Amyotrophic Lateral Sclerosis)
  8. M19-753 Phase 1 · AbbVie Deutschland GmbH · Myelofibrosis, Myeloproliferative Neoplasms

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 12097185

    Compositions comprising ciprofloxacin and celecoxib

    Expires Mon Sep 19 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is celecoxib?

celecoxib (APX-CELECOXIB) is a cyclooxygenase-2 inhibitor. Associated with Viatris Pharmaceuticals Co.,. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for celecoxib?

APX-CELECOXIB is a marketed brand name for celecoxib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of celecoxib?

celecoxib 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.