Last reviewed 2026-05-18 · How we verify

APEX-002-A02

Apex Labs Ltd. · Phase 2 active Small molecule Quality 0/100

APEX-002-A02 is a Small molecule drug developed by Apex Labs Ltd.. It is currently in Phase 2 development. Also known as: psilocybin.

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	APEX-002-A02
Also known as	psilocybin
Sponsor	Apex Labs Ltd.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Evaluation of Psilocybin-Assisted Psychotherapy in Treating Severe Depression in Patients With PTSD (PHASE2)

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:

APEX-002-A02 CI brief — competitive landscape report
APEX-002-A02 updates RSS · CI watch RSS
Apex Labs Ltd. portfolio CI

Frequently asked questions about APEX-002-A02

What is APEX-002-A02?

APEX-002-A02 is a Small molecule drug developed by Apex Labs Ltd..

Who makes APEX-002-A02?

APEX-002-A02 is developed by Apex Labs Ltd. (see full Apex Labs Ltd. pipeline at /company/apex-labs-ltd).

Is APEX-002-A02 also known as anything else?

APEX-002-A02 is also known as psilocybin.

What development phase is APEX-002-A02 in?

APEX-002-A02 is in Phase 2.

Manufacturer: Apex Labs Ltd. — full pipeline
Also known as: psilocybin

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