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etoricoxib (MK0663)
etoricoxib (MK0663) is a Small molecule drug developed by Organon and Co. It is currently in Phase 3 development. Also known as: MK0663.
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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).
| 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 | etoricoxib (MK0663) |
|---|---|
| Also known as | MK0663 |
| Sponsor | Organon and Co |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
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:
- etoricoxib (MK0663) CI brief — competitive landscape report
- etoricoxib (MK0663) updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about etoricoxib (MK0663)
What is etoricoxib (MK0663)?
Who makes etoricoxib (MK0663)?
Is etoricoxib (MK0663) also known as anything else?
What development phase is etoricoxib (MK0663) in?
Related
- Manufacturer: Organon and Co — full pipeline
- Also known as: MK0663
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing