Product Description
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild-to-moderate pain, and helps to relieve symptoms of arthritis (eg, osteoarthritis or rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will only help you as long as you continue to take it. (Sourced from: https://www.mayoclinic.org/drugs-supplements/diclofenac-oral-route/description/drg-20069748)
Mechanisms of Action: COX2 Inhibitor, COX1 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral, Transdermal, Topical
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, China, Czech Republic, Denmark, Germany, Greece, Italy, Japan, Poland, United States
Active Clinical Trial Count: 23
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Acute Pain|Cancer Pain|Chronic Pain|Keratosis, Actinic|Low Back Pain|Osteoarthritis, Knee
Phase 2: Musculoskeletal Pain
Phase 1: Healthy Volunteers|Osteoarthritis|Pain Unspecified
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| BF-01-2023 | P1 |
Recruiting |
Pain Unspecified |
2026-02-01 |
50% |
2025-03-01 |
Primary Endpoints |
| ACTRN12623000273684 | P2 |
Completed |
Osteoarthritis, Knee|Musculoskeletal Pain |
2024-12-03 |
2025-04-20 |
Treatments |
|
| DI-OR-PA | P3 |
Not yet recruiting |
Low Back Pain |
2027-03-31 |
|||
| AMZ001 | P3 |
Recruiting |
Osteoarthritis, Knee |
2025-11-01 |
42% |
2025-03-01 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| EPDICTIO75+4F01-2022 | P3 |
Active, not recruiting |
Chronic Pain|Acute Pain|Low Back Pain |
2025-03-31 |
2025-05-02 |
Treatments |
|
| 5%-ige KOH-Lösung vs. Placebo und Diclofenac-Gel zur Behandlung der Aktinischen Keratose | P3 |
Active, not recruiting |
Keratosis, Actinic |
2023-05-15 |
2022-03-13 |
Treatments |
|
| OA-01-2022 | P1 |
Recruiting |
Osteoarthritis |
2026-05-01 |
50% |
2025-02-28 |
Primary Completion Date|Primary Endpoints |
| ACTRN12622001391763 | P1 |
Completed |
Osteoarthritis |
2023-01-18 |
2024-08-29 |
Treatments |
|
| KP-01-2024 | P2 |
Recruiting |
Osteoarthritis, Knee |
2026-02-01 |
50% |
2025-02-13 |
Primary Endpoints |
| KP-01-2022 | P2 |
Completed |
Osteoarthritis, Knee |
2023-12-31 |
50% |
2024-02-29 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| AMZ001-007 | P3 |
Not yet recruiting |
Osteoarthritis, Knee |
2025-09-15 |
2025-05-01 |
Treatments |
|
| DITH/VER | P3 |
Recruiting |
Low Back Pain|Acute Pain |
2025-01-02 |
2025-05-02 |
Treatments |
|
| HP-5000-US-07 | P3 |
Not yet recruiting |
Osteoarthritis, Knee |
2022-08-01 |
15% |
2020-11-30 |
Primary Endpoints|Treatments |
| JapicCTI-205103 | P3 |
Active |
Low Back Pain |
2021-07-31 |
|||
| JapicCTI-205291 | P3 |
Planned |
Low Back Pain |
2020-10-31 |
|||
| Diclofenac 2% in improvement of pain symptoms | P3 |
Active, not recruiting |
Acute Pain |
2017-11-28 |
2022-03-13 |
Treatments |
|
| JapicCTI-173651 | P3 |
Active |
Cancer Pain |
None |
|||
| AMZ001 | P1 |
Active, not recruiting |
Healthy Volunteers |
2025-06-10 |
88% |
2025-07-02 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| CTR20250470 | P1 |
Completed |
Pain Unspecified|Healthy Volunteers |
2025-03-21 |
2025-05-04 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
| ACTRN12624000341527 | P1 |
Recruiting |
Osteoarthritis, Knee |
2024-07-14 |
2024-08-29 |
Treatments |
|
| AMZ001-008 | P1 |
Completed |
Healthy Volunteers |
2023-12-27 |
12% |
2025-04-10 |
Primary Endpoints|Study Completion Date |
| ACTRN12623000261617 | P1 |
Completed |
Musculoskeletal Pain|Osteoarthritis, Knee |
2023-11-17 |
2024-08-29 |
Treatments |
|
| DARE-PDM1 | P1 |
Completed |
Pain Unspecified |
2023-10-10 |
12% |
2025-09-05 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date |
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