Last reviewed 2026-05-29 · How we verify

RXDX-105

Hoffmann-La Roche · Phase 2 active Small molecule ✓ Verified May 2026

RXDX-105 is a Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 2 development. Also known as: CEP-32496, AC013773.

RXDX-105 is a cell division cycle 7-related protein kinase inhibitor, classified as an inhibitor. It is being studied for the treatment of cancers with RET alterations, including non-small cell lung cancer, ovarian cancer, and cancers with RET gene mutations.

Likelihood of approval

18.3% 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).
Big-pharma sponsor +3.0pp
Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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	RXDX-105
Also known as	CEP-32496, AC013773
Sponsor	Hoffmann-La Roche
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

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:

RXDX-105 CI brief — competitive landscape report
RXDX-105 updates RSS · CI watch RSS
Hoffmann-La Roche portfolio CI

Frequently asked questions about RXDX-105

What is RXDX-105?

RXDX-105 is a Small molecule drug developed by Hoffmann-La Roche.

Who makes RXDX-105?

RXDX-105 is developed by Hoffmann-La Roche (see full Hoffmann-La Roche pipeline at /company/roche).

Is RXDX-105 also known as anything else?

RXDX-105 is also known as CEP-32496, AC013773.

What development phase is RXDX-105 in?

RXDX-105 is in Phase 2.

Manufacturer: Hoffmann-La Roche — full pipeline
Also known as: CEP-32496, AC013773

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