Wednesday, July 8, 2026

Drug profile · INN

diclofenac

diclofenac (CLONAC 25) is a cyclooxygenase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved NMPA: clinical trials
US status approved
Patents linked 0
Pipeline programs 12
News articles 0
Drug details — diclofenac
US status
approved
Class
Route
ORAL
Patents
0
Programs
12
Data quality
0.84

Quick answer

diclofenac (CLONAC 25) is a cyclooxygenase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN diclofenac
Brand CLONAC 25
Mechanism Cyclooxygenase inhibitor
Target Cyclooxygenase
Route ORAL
Formulation CAPSULE

Mechanism of action

Cyclooxygenase inhibitor

Primary target: Cyclooxygenase

Approval history

Authority Status Date
FDA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. AMZ001 Diclofenac gel Phase 3 · KeyZell · Osteoarthritis of Knee
  2. DR200091 Phase 3 · Tour Hekla · Thrombotic episodes in superficial venous malformations in c
  3. Diclofenac Sodium Topical Gel, 1% Phase 3 · Amneal Pharma Europe · Osteoarthritis
  4. Diclofenac sodium Phase 3 · Teva Pharma · Actinic Keratosis
  5. Diclofenac Phase 2 · Atrium Therapeutics · Wobenzym
  6. compound diclofenac sodium Phase 2 · First People's Hospital · Acute Abdominal Pain
  7. 400314 Phase 1 · Haleon - Gebro · For the local, symptomatic treatment of pain in acute bruise
  8. Radiolabelled Diclofenac Tablet A Phase 1 · BRIGHT MINDS BIOSCIENCES · Pain

Related & competitor drugs

  1. aspirin Cyclooxygenase inhibitor
  2. bromfenac sodium Cyclooxygenase inhibitor
  3. diclofenac potassium Cyclooxygenase inhibitor
  4. diclofenac sodium Cyclooxygenase inhibitor
  5. diflunisal Nervous system (N02)
  6. fenoprofen calcium Cyclooxygenase inhibitor

Frequently asked questions

What is diclofenac?

diclofenac (CLONAC 25) is a cyclooxygenase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for diclofenac?

CLONAC 25 is a marketed brand name for diclofenac. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of diclofenac?

diclofenac 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.