Product Description
Naproxen is FDA-approved for treating acute gout, ankylosing spondylitis, bursitis, polyarticular juvenile idiopathic arthritis, osteoarthritis, tendonitis, rheumatoid arthritis, pain, and primary dysmenorrhea. It is the first-line treatment for acute gouty arthritis, osteoarthritis, musculoskeletal pain, inflammation, and dysmenorrhea. While naproxen and other NSAIDs are approved for the treatment of inflammatory arthropathies such as rheumatoid arthritis and ankylosing spondylitis, they do not alter the course of the disease, nor do they prevent joint and soft tissue destruction that are common sequelae of these diseases. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/30247840/)
Mechanisms of Action: COX Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
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 | 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: Acute Pain | Pain Unspecified | Arthritis, Juvenile | Arthritis, Rheumatoid | Spondylitis, Ankylosing | Spondylitis | Arthritis | Bursitis | Gout | Osteoarthritis | Acute Pain | Pain Unspecified | Arthritis, Rheumatoid | Spondylitis, Ankylosing | Spondylitis | Arthritis | Bursitis | Gout | Osteoarthritis | Acute Pain | Pain Unspecified | Arthritis, Juvenile | Arthritis, Rheumatoid | Spondylitis, Ankylosing | Spondylitis | Arthritis | Osteoarthritis | Cluster Headache | Migraine Disorders | Migraine with Aura | Migraine without Aura | Headache
Known Adverse Events: Abdominal Pain | Headache | Pain Unspecified | Ecchymosis | Dyspepsia | Edema | Gastritis | Diarrhea | Chest Pain | Dizziness | Neck Pain
Company: Elanco Animal Health
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Brazil, Korea, United States
Active Clinical Trial Count: 11
Highest Development Phases
Phase 3: Migraine Disorders|Pain, Postoperative|Toothache
Phase 1: Healthy Volunteers|Inflammation|Low Back Pain|Pain Unspecified|Peripheral Arterial Disease|Peripheral Vascular Diseases|Shoulder Pain
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| EF167 | P3 |
Recruiting |
Migraine Disorders |
2025-01-30 |
|
| NCT06511973 | P1 |
Completed |
Low Back Pain|Inflammation|Shoulder Pain |
2024-08-20 |
|
| JW23103 | P1 |
Not yet recruiting |
Healthy Volunteers |
2024-08-01 |
28% |
| JW23103 | P1 |
Not yet recruiting |
Healthy Volunteers |
2024-08-01 |
28% |
| NCT06415019 | P1 |
Completed |
Low Back Pain|Shoulder Pain|Inflammation |
2024-08-01 |