Last reviewed 2026-06-02 · How we verify

CHEMBL1201391

Phase 1 active ✓ Verified Jun 2026 Quality 0/100

CHEMBL1201391 is a drug. It is currently in Phase 1 development.

CHEMBL1201391 is a small molecule with the synonyms SIMVASTATIN ACID, SIMVASTATIN CARBOXYLIC ACID, SIMVASTATIN HYDROXY ACID, TENIVASTATIN, and TENIVASTATINA. It is a metabolite or derivative of simvastatin, a statin medication used to lower cholesterol levels.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	CHEMBL1201391
Phase	Phase 1

Approved indications

No approved indications tracked.

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:

CHEMBL1201391 CI brief — competitive landscape report
CHEMBL1201391 updates RSS · CI watch RSS
portfolio CI

Frequently asked questions about CHEMBL1201391

What is CHEMBL1201391?

CHEMBL1201391 is a pharmaceutical drug.

What development phase is CHEMBL1201391 in?

CHEMBL1201391 is in Phase 1.

Manufacturer: — full pipeline

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