Last reviewed 2026-04-19 · How we verify

GTX-B001

Granular Therapeutics Limited · Phase 1 active Small molecule

GTX-B001 is a Small molecule drug developed by Granular Therapeutics Limited. It is currently in Phase 1 development. Also known as: ALY-301.

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	GTX-B001
Also known as	ALY-301
Sponsor	Granular Therapeutics Limited
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria (PHASE1)

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:

GTX-B001 CI brief — competitive landscape report
GTX-B001 updates RSS · CI watch RSS
Granular Therapeutics Limited portfolio CI

Frequently asked questions about GTX-B001

What is GTX-B001?

GTX-B001 is a Small molecule drug developed by Granular Therapeutics Limited.

Who makes GTX-B001?

GTX-B001 is developed by Granular Therapeutics Limited (see full Granular Therapeutics Limited pipeline at /company/granular-therapeutics-limited).

Is GTX-B001 also known as anything else?

GTX-B001 is also known as ALY-301.

What development phase is GTX-B001 in?

GTX-B001 is in Phase 1.

Manufacturer: Granular Therapeutics Limited — full pipeline
Also known as: ALY-301

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