Last reviewed 2026-05-27 · How we verify

Chiglitazar 64mg

Beijing Friendship Hospital · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

Chiglitazar 64mg is a Small molecule drug developed by Beijing Friendship Hospital. It is currently in Phase 1 development.

Chiglitazar 64mg is a small molecule peroxisome proliferator-activated receptor agonist used to treat Metabolic Dysfunction Associated Fatty Liver Disease and Compensated Liver Cirrhosis. It is being studied in a randomized double-blind controlled trial to evaluate its efficacy and safety in patients with MAFLD-related cirrhosis.

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	Chiglitazar 64mg
Sponsor	Beijing Friendship Hospital
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

The Efficacy and Safety of Chiglitazar in Patients with MAFLD-related Cirrhosis (NA)

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:

Chiglitazar 64mg CI brief — competitive landscape report
Chiglitazar 64mg updates RSS · CI watch RSS
Beijing Friendship Hospital portfolio CI

Frequently asked questions about Chiglitazar 64mg

What is Chiglitazar 64mg?

Chiglitazar 64mg is a Small molecule drug developed by Beijing Friendship Hospital.

Who makes Chiglitazar 64mg?

Chiglitazar 64mg is developed by Beijing Friendship Hospital (see full Beijing Friendship Hospital pipeline at /company/beijing-friendship-hospital).

What development phase is Chiglitazar 64mg in?

Chiglitazar 64mg is in Phase 1.

Manufacturer: Beijing Friendship Hospital — full pipeline

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