Last reviewed 2026-05-14 · How we verify

GDC-9545 Solution for Infusion

Genentech, Inc. · Phase 1 active Small molecule

GDC-9545 Solution for Infusion is a Small molecule drug developed by Genentech, Inc.. It is currently in Phase 1 development. Also known as: Giredestrant, RO7197597, RG6171.

GDC-9545 is an investigational small molecule drug being developed by Genentech, Inc. It is currently in early-stage clinical trials, with one completed Phase 1 study focusing on its pharmacokinetics and bioavailability. The drug has no FDA-approved label and is not yet commercially available.

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	GDC-9545 Solution for Infusion
Also known as	Giredestrant, RO7197597, RG6171
Sponsor	Genentech, Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

GDC-9545 Solution for Infusion CI brief — competitive landscape report
GDC-9545 Solution for Infusion updates RSS · CI watch RSS
Genentech, Inc. portfolio CI

Frequently asked questions about GDC-9545 Solution for Infusion

What is GDC-9545 Solution for Infusion?

GDC-9545 Solution for Infusion is a Small molecule drug developed by Genentech, Inc..

Who makes GDC-9545 Solution for Infusion?

GDC-9545 Solution for Infusion is developed by Genentech, Inc. (see full Genentech, Inc. pipeline at /company/genentech-inc).

Is GDC-9545 Solution for Infusion also known as anything else?

GDC-9545 Solution for Infusion is also known as Giredestrant, RO7197597, RG6171.

What development phase is GDC-9545 Solution for Infusion in?

GDC-9545 Solution for Infusion is in Phase 1.

Manufacturer: Genentech, Inc. — full pipeline
Also known as: Giredestrant, RO7197597, RG6171

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