Last reviewed 2026-05-18 · How we verify

AN2025

Adlai Nortye Biopharma Co., Ltd. · Phase 1 active Small molecule Quality 0/100

AN2025 is a Small molecule drug developed by Adlai Nortye Biopharma Co., Ltd.. It is currently in Phase 1 development. Also known as: BKM120.

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	AN2025
Also known as	BKM120
Sponsor	Adlai Nortye Biopharma Co., Ltd.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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.

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:

AN2025 CI brief — competitive landscape report
AN2025 updates RSS · CI watch RSS
Adlai Nortye Biopharma Co., Ltd. portfolio CI

Frequently asked questions about AN2025

What is AN2025?

AN2025 is a Small molecule drug developed by Adlai Nortye Biopharma Co., Ltd..

Who makes AN2025?

AN2025 is developed by Adlai Nortye Biopharma Co., Ltd. (see full Adlai Nortye Biopharma Co., Ltd. pipeline at /company/adlai-nortye-biopharma-co-ltd).

Is AN2025 also known as anything else?

AN2025 is also known as BKM120.

What development phase is AN2025 in?

AN2025 is in Phase 1.

Manufacturer: Adlai Nortye Biopharma Co., Ltd. — full pipeline
Also known as: BKM120

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