Last reviewed 2026-05-24 · How we verify

ALK4290

Alkahest, Inc. · Phase 2 active Small molecule ✓ Verified May 2026 Quality 10/100

ALK4290 is a Small molecule drug developed by Alkahest, Inc.. It is currently in Phase 2 development. Also known as: AKST4290, BI 144807.

ALK4290 is being studied in a clinical trial for the treatment of Wet Age-related Macular Degeneration. The trial, NCT03558061, is a single-arm, open-label study evaluating the therapeutic effects and safety of a 6-week treatment regimen of ALK4290 in patients with newly diagnosed Wet Age-related Macular Degeneration.

Likelihood of approval

15.3% 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).

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	ALK4290
Also known as	AKST4290, BI 144807
Sponsor	Alkahest, Inc.
Modality	Small molecule
Phase	Phase 2

Approved indications

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:

ALK4290 CI brief — competitive landscape report
ALK4290 updates RSS · CI watch RSS
Alkahest, Inc. portfolio CI

Frequently asked questions about ALK4290

What is ALK4290?

ALK4290 is a Small molecule drug developed by Alkahest, Inc..

Who makes ALK4290?

ALK4290 is developed by Alkahest, Inc. (see full Alkahest, Inc. pipeline at /company/alkahest-inc).

Is ALK4290 also known as anything else?

ALK4290 is also known as AKST4290, BI 144807.

What development phase is ALK4290 in?

ALK4290 is in Phase 2.

Manufacturer: Alkahest, Inc. — full pipeline
Also known as: AKST4290, BI 144807

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