Friday, July 10, 2026

Drug profile · INN

alectinib hydrochloride

alectinib hydrochloride (ALECENSA) is a eml4-alk. Route of administration: oral. Current US regulatory status: approved.

FDA: approved PMDA: approved
US status approved
Patents linked 0
Pipeline programs 1
News articles 3
Drug details — alectinib hydrochloride

Quick answer

alectinib hydrochloride (ALECENSA) is a eml4-alk. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN alectinib hydrochloride
Brand ALECENSA
Mechanism EML4-ALK
Target ALK tyrosine kinase receptor
Route ORAL
Formulation CAPSULE

Mechanism of action

EML4-ALK

Primary target: ALK tyrosine kinase receptor

Approval history

Authority Status Date
FDA approved
PMDA approved

Recent coverage

Pipeline programs

  1. Alectinib Phase 2 · Chinese Academy of · Bone Cancer

Related & competitor drugs

  1. brigatinib Antineoplastic and immunomodulating agents (L01)
  2. ceritinib Antineoplastic and immunomodulating agents (L01)
  3. crizotinib Antineoplastic and immunomodulating agents (L01)
  4. entrectinib Antineoplastic and immunomodulating agents (L01)
  5. lorlatinib Antineoplastic and immunomodulating agents (L01)
  6. ensartinib ALK tyrosine kinase receptor inhibitor

Frequently asked questions

What is alectinib hydrochloride?

alectinib hydrochloride (ALECENSA) is a eml4-alk. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for alectinib hydrochloride?

ALECENSA is a marketed brand name for alectinib hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of alectinib hydrochloride?

alectinib hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.