Last reviewed 2026-05-19 · How we verify

CM082 with fed or fasting

AnewPharma · Phase 1 active Small molecule ✓ Verified May 2026

CM082 with fed or fasting is a Small molecule drug developed by AnewPharma. It is currently in Phase 1 development.

CM082 is a stem cell growth factor receptor inhibitor, specifically targeting the Mast/stem cell growth factor receptor Kit. It is being studied in a clinical trial (NCT04126668) for its effect on advanced malignant solid tumors, with a focus on its pharmacokinetics when taken with food versus fasting.

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	CM082 with fed or fasting
Sponsor	AnewPharma
Modality	Small molecule
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:

CM082 with fed or fasting CI brief — competitive landscape report
CM082 with fed or fasting updates RSS · CI watch RSS
AnewPharma portfolio CI

Frequently asked questions about CM082 with fed or fasting

What is CM082 with fed or fasting?

CM082 with fed or fasting is a Small molecule drug developed by AnewPharma.

Who makes CM082 with fed or fasting?

CM082 with fed or fasting is developed by AnewPharma (see full AnewPharma pipeline at /company/anewpharma).

What development phase is CM082 with fed or fasting in?

CM082 with fed or fasting is in Phase 1.

Manufacturer: AnewPharma — full pipeline

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