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MK0663, etoricoxib
MK0663, etoricoxib is a COX-2 inhibitor Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Osteoarthritis, Rheumatoid arthritis.
Etoricoxib is a nonsteroidal anti-inflammatory drug (NSAID) that selectively inhibits COX-2, reducing prostaglandin synthesis and inflammation.
Etoricoxib is a nonsteroidal anti-inflammatory drug (NSAID) that selectively inhibits COX-2, reducing prostaglandin synthesis and inflammation. Used for Osteoarthritis, Rheumatoid arthritis.
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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 | MK0663, etoricoxib |
|---|---|
| Sponsor | Organon and Co |
| Drug class | COX-2 inhibitor |
| Target | COX-2 |
| Modality | Small molecule |
| Therapeutic area | Rheumatology |
| Phase | Phase 3 |
Mechanism of action
This selective inhibition of COX-2 results in reduced inflammation and pain, making it effective for treating conditions such as osteoarthritis and rheumatoid arthritis. Etoricoxib's mechanism of action is distinct from traditional NSAIDs, which inhibit both COX-1 and COX-2 enzymes.
Approved indications
- Osteoarthritis
- Rheumatoid arthritis
Common side effects
- Gastrointestinal upset
- Headache
- Dizziness
Key clinical trials
- Comparative Bioavailability Study Between Etoricoxib / Betamethasone Administered Individually or in Combination (PHASE1)
- Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers (PHASE1)
- Survey of Osteoarthritis Real World Therapies (MK-0663-140)
- An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064) (PHASE3)
- A Study to Assess Etoricoxib Versus Diclofenac in Chinese Patients With Osteoarthritis of the Knee or Hip (0663-080)(COMPLETED) (PHASE4)
- Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED) (PHASE3)
- Quality of Life With Arcoxia in Women With Dysmenorrhea (0663-094) (PHASE4)
- A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED) (PHASE3)
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:
- MK0663, etoricoxib CI brief — competitive landscape report
- MK0663, etoricoxib updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about MK0663, etoricoxib
What is MK0663, etoricoxib?
How does MK0663, etoricoxib work?
What is MK0663, etoricoxib used for?
Who makes MK0663, etoricoxib?
What drug class is MK0663, etoricoxib in?
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What does MK0663, etoricoxib target?
Related
- Drug class: All COX-2 inhibitor drugs
- Target: All drugs targeting COX-2
- Manufacturer: Organon and Co — full pipeline
- Therapeutic area: All drugs in Rheumatology
- Indication: Drugs for Osteoarthritis
- Indication: Drugs for Rheumatoid arthritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing