Last reviewed 2026-05-18 · How we verify

GR1014-CG 2.4%

Graegis Pharmaceuticals Ltd · Phase 2 active Small molecule Quality 10/100

GR1014-CG 2.4% is a Small molecule drug developed by Graegis Pharmaceuticals Ltd. It is currently in Phase 2 development.

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	GR1014-CG 2.4%
Sponsor	Graegis Pharmaceuticals Ltd
Modality	Small molecule
Phase	Phase 2

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

A Study of GR1014 Cutaneous Gel for the Prevention of Skin Reactions Caused by Radiation Therapy for Breast Cancer (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:

GR1014-CG 2.4% CI brief — competitive landscape report
GR1014-CG 2.4% updates RSS · CI watch RSS
Graegis Pharmaceuticals Ltd portfolio CI

Frequently asked questions about GR1014-CG 2.4%

What is GR1014-CG 2.4%?

GR1014-CG 2.4% is a Small molecule drug developed by Graegis Pharmaceuticals Ltd.

Who makes GR1014-CG 2.4%?

GR1014-CG 2.4% is developed by Graegis Pharmaceuticals Ltd (see full Graegis Pharmaceuticals Ltd pipeline at /company/graegis-pharmaceuticals-ltd).

What development phase is GR1014-CG 2.4% in?

GR1014-CG 2.4% is in Phase 2.

Manufacturer: Graegis Pharmaceuticals Ltd — full pipeline

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