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, Topical, Transdermal
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 ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2025-521578-32-00 |
DI-OR-PA | P3 |
Not yet recruiting |
Low Back Pain |
2027-03-31 |
|||
NCT05254574 |
OA-01-2022 | P1 |
Recruiting |
Osteoarthritis |
2026-05-01 |
50% |
2025-02-28 |
Primary Completion Date|Primary Endpoints |
NCT05883241 |
BF-01-2023 | P1 |
Recruiting |
Pain Unspecified |
2026-02-01 |
50% |
2025-03-01 |
Primary Endpoints |
NCT06693648 |
AMZ001 | P3 |
Active, not recruiting |
Osteoarthritis, Knee |
2025-12-01 |
42% |
2025-11-14 |
Primary Completion Date|Primary Endpoints|Treatments|Trial Status |
2024-518753-42-00 |
EPDICTIO75+4F01-2022 | P3 |
Active, not recruiting |
Chronic Pain|Acute Pain|Low Back Pain |
2025-03-31 |
2025-05-02 |
Treatments |
|
ACTRN12623000273684 |
ACTRN12623000273684 | P2 |
Completed |
Osteoarthritis, Knee|Musculoskeletal Pain |
2024-12-03 |
2025-04-20 |
Treatments |
|
2019-003678-16 |
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 |
|
NCT06257537 |
KP-01-2024 | P2 |
Recruiting |
Osteoarthritis, Knee |
2026-02-01 |
50% |
2025-02-13 |
Primary Endpoints |
2024-517404-11-00 |
AMZ001-007 | P3 |
Not yet recruiting |
Osteoarthritis, Knee |
2025-09-15 |
2025-05-01 |
Treatments |
|
NCT06729073 |
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 |
CTR20250470 | P1 |
Completed |
Healthy Volunteers|Pain Unspecified |
2025-03-21 |
2025-05-04 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
2024-512786-13-00 |
DITH/VER | P3 |
Recruiting |
Low Back Pain|Acute Pain |
2025-01-02 |
2025-05-02 |
Treatments |
|
ACTRN12624000341527 |
ACTRN12624000341527 | P1 |
Recruiting |
Osteoarthritis, Knee |
2024-07-14 |
2024-08-29 |
Treatments |
|
NCT05882812 |
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 |
NCT05968482 |
AMZ001-008 | P1 |
Completed |
Healthy Volunteers |
2023-12-27 |
12% |
2025-04-10 |
Primary Endpoints|Study Completion Date |
ACTRN12623000261617 |
ACTRN12623000261617 | P1 |
Completed |
Osteoarthritis, Knee|Musculoskeletal Pain |
2023-11-17 |
2024-08-29 |
Treatments |
|
NCT05752526 |
DARE-PDM1 | P1 |
Completed |
Pain Unspecified |
2023-10-10 |
12% |
2025-09-05 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date |
ACTRN12622001391763 |
ACTRN12622001391763 | P1 |
Completed |
Osteoarthritis |
2023-01-18 |
2024-08-29 |
Treatments |
|
NCT04640675 |
HP-5000-US-07 | P3 |
Not yet recruiting |
Osteoarthritis, Knee |
2022-08-01 |
15% |
2020-11-30 |
Primary Endpoints|Treatments |
JapicCTI-205103 |
JapicCTI-205103 | P3 |
Active |
Low Back Pain |
2021-07-31 |
|||
JapicCTI-205291 |
JapicCTI-205291 | P3 |
Planned |
Low Back Pain |
2020-10-31 |
|||
2015-004102-42 |
Diclofenac 2% in improvement of pain symptoms | P3 |
Active, not recruiting |
Acute Pain |
2017-11-28 |
2022-03-13 |
Treatments |
|
JapicCTI-173651 |
JapicCTI-173651 | P3 |
Active |
Cancer Pain |
None |