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COX-2 inhibitor

Seoul National University Hospital · Phase 3 active Small molecule

COX-2 inhibitor is a COX-2 selective inhibitor Small molecule drug developed by Seoul National University Hospital. It is currently in Phase 3 development for Rheumatoid arthritis, Osteoarthritis, Acute pain. Also known as: EtoriCoxib.

COX-2 inhibitors selectively block cyclooxygenase-2 enzyme to reduce prostaglandin production and inflammation without significantly affecting COX-1-mediated gastric protection.

COX-2 inhibitors selectively block cyclooxygenase-2 enzyme to reduce prostaglandin production and inflammation without significantly affecting COX-1-mediated gastric protection. Used for Rheumatoid arthritis, Osteoarthritis, Acute pain.

Likelihood of approval
59.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameCOX-2 inhibitor
Also known asEtoriCoxib
SponsorSeoul National University Hospital
Drug classCOX-2 selective inhibitor
TargetCOX-2 (Cyclooxygenase-2)
ModalitySmall molecule
Therapeutic areaRheumatology / Pain Management
PhasePhase 3

Mechanism of action

COX-2 is an inducible enzyme upregulated during inflammation and produces prostaglandins that drive pain, fever, and inflammatory responses. By selectively inhibiting COX-2 while sparing COX-1, these drugs reduce inflammatory prostaglandins while theoretically preserving the protective prostaglandins in the gastrointestinal tract. This selectivity was designed to provide anti-inflammatory and analgesic benefits with reduced GI toxicity compared to non-selective NSAIDs.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about COX-2 inhibitor

What is COX-2 inhibitor?

COX-2 inhibitor is a COX-2 selective inhibitor drug developed by Seoul National University Hospital, indicated for Rheumatoid arthritis, Osteoarthritis, Acute pain.

How does COX-2 inhibitor work?

COX-2 inhibitors selectively block cyclooxygenase-2 enzyme to reduce prostaglandin production and inflammation without significantly affecting COX-1-mediated gastric protection.

What is COX-2 inhibitor used for?

COX-2 inhibitor is indicated for Rheumatoid arthritis, Osteoarthritis, Acute pain, Ankylosing spondylitis.

Who makes COX-2 inhibitor?

COX-2 inhibitor is developed by Seoul National University Hospital (see full Seoul National University Hospital pipeline at /company/seoul-national-university-hospital).

Is COX-2 inhibitor also known as anything else?

COX-2 inhibitor is also known as EtoriCoxib.

What drug class is COX-2 inhibitor in?

COX-2 inhibitor belongs to the COX-2 selective inhibitor class. See all COX-2 selective inhibitor drugs at /class/cox-2-selective-inhibitor.

What development phase is COX-2 inhibitor in?

COX-2 inhibitor is in Phase 3.

What are the side effects of COX-2 inhibitor?

Common side effects of COX-2 inhibitor include Cardiovascular events (myocardial infarction, stroke), Gastrointestinal ulceration, Hypertension, Edema, Dyspepsia.

What does COX-2 inhibitor target?

COX-2 inhibitor targets COX-2 (Cyclooxygenase-2) and is a COX-2 selective inhibitor.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing