Last reviewed 2026-05-26 · How we verify

TENIDAP

Phase 2 active Small molecule ✓ Verified May 2026 Quality 33/100

TENIDAP is a tenidap drug. It is currently in Phase 2 development for Rheumatoid arthritis.

TENIDAP works by inhibiting the enzyme Prostaglandin G/H synthase 1, which plays a key role in the production of inflammatory mediators.

TENIDAP is a small molecule. It is also known by the synonyms CP-66,248 and CP-66248.

Likelihood of approval

16.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	TENIDAP
Drug class	tenidap
Target	Prostaglandin G/H synthase 1
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Think of it like a fire alarm in a building. When there's an injury or infection, the body sends out chemical signals to alert the immune system to respond. TENIDAP helps to silence this alarm by blocking the production of these chemical signals, which reduces inflammation and pain.

Approved indications

Rheumatoid arthritis

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

TENIDAP CI brief — competitive landscape report
TENIDAP updates RSS · CI watch RSS

Frequently asked questions about TENIDAP

What is TENIDAP?

TENIDAP is a tenidap drug, indicated for Rheumatoid arthritis.

How does TENIDAP work?

TENIDAP works by inhibiting the enzyme Prostaglandin G/H synthase 1, which plays a key role in the production of inflammatory mediators.

What is TENIDAP used for?

TENIDAP is indicated for Rheumatoid arthritis.

What drug class is TENIDAP in?

TENIDAP belongs to the tenidap class. See all tenidap drugs at /class/tenidap.

What development phase is TENIDAP in?

TENIDAP is in Phase 2.

What does TENIDAP target?

TENIDAP targets Prostaglandin G/H synthase 1 and is a tenidap.

Drug class: All tenidap drugs
Target: All drugs targeting Prostaglandin G/H synthase 1
Therapeutic area: All drugs in Immunology
Indication: Drugs for Rheumatoid arthritis

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