Last reviewed 2026-05-14 · How we verify

Alectnib

Hoffmann-La Roche · Phase 3 active Small molecule Quality 25/100

Alectnib is a Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development. Also known as: RO5424802.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Alectnib
Also known as	RO5424802
Sponsor	Hoffmann-La Roche
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

Blood creatine phosphokinase increased
Constipation
Aspartate aminotransferase increased
Alanine aminotransferase increased
Blood bilirubin increased
COVID-19
Myalgia
Blood alkaline phosphatase increased
Anaemia
Blood creatinine increased
Cough
Fatigue

Key clinical trials

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer (PHASE3)

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:

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

Frequently asked questions about Alectnib

What is Alectnib?

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

Who makes Alectnib?

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

Is Alectnib also known as anything else?

Alectnib is also known as RO5424802.

What development phase is Alectnib in?

Alectnib is in Phase 3.

What are the side effects of Alectnib?

Common side effects of Alectnib include Blood creatine phosphokinase increased, Constipation, Aspartate aminotransferase increased, Alanine aminotransferase increased, Blood bilirubin increased, COVID-19.

Manufacturer: Hoffmann-La Roche — full pipeline
Therapeutic area: All drugs in Other
Also known as: RO5424802

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