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Comparator: naproxen sodium
Comparator: naproxen sodium is a Nonsteroidal anti-inflammatory drug (NSAID) Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Mild to moderate pain, Rheumatoid arthritis, Osteoarthritis. Also known as: naproxen sodium.
Naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation, pain, and fever.
Naproxen sodium is a small molecule that acts as a cyclooxygenase inhibitor, belonging to the drug class of inhibitors. It is used to treat conditions such as osteoarthritis, migraine, and veisalgia, as well as to provide gastro-protective effects in patients with osteoarthritis.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Comparator: naproxen sodium |
|---|---|
| Also known as | naproxen sodium |
| Sponsor | Organon and Co |
| Drug class | Nonsteroidal anti-inflammatory drug (NSAID) |
| Target | COX-1, COX-2 |
| Modality | Small molecule |
| Therapeutic area | Pain Management, Rheumatology, Inflammation |
| Phase | Phase 3 |
Mechanism of action
Naproxen sodium blocks both COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammatory responses and pain signaling. The sodium salt formulation allows for faster absorption and more rapid onset of action compared to naproxen base. This mechanism makes it effective for acute and chronic pain relief, particularly in inflammatory conditions.
Approved indications
- Mild to moderate pain
- Rheumatoid arthritis
- Osteoarthritis
- Menstrual cramps
- Fever
Common side effects
- Gastrointestinal upset (nausea, dyspepsia)
- Abdominal pain
- Headache
- Dizziness
- Increased cardiovascular risk (with chronic use)
- Renal impairment (with chronic use)
Key clinical trials
- An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064) (PHASE3)
- A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108) (PHASE3)
- Colchicine Or Naproxen Treatment for ACute gouT (PHASE4)
- Study to Evaluate the Pharmacokinetics and Pharmacodynamics of JMI-001 (PHASE1)
- A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231) (PHASE4)
- Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks (PHASE3)
- Treximet Early Intervention Adolescent Migraine (PHASE2, PHASE3)
- Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Comparator: naproxen sodium CI brief — competitive landscape report
- Comparator: naproxen sodium updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about Comparator: naproxen sodium
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Related
- Drug class: All Nonsteroidal anti-inflammatory drug (NSAID) drugs
- Target: All drugs targeting COX-1, COX-2
- Manufacturer: Organon and Co — full pipeline
- Therapeutic area: All drugs in Pain Management, Rheumatology, Inflammation
- Indication: Drugs for Mild to moderate pain
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Osteoarthritis
- Also known as: naproxen sodium
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing