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alectinib

Trade name: alecensa

Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Dec 11, 2015

Alectinib is a second generation oral drug that selectively inhibits the activity of anaplastic lymphoma kinase (ALK) tyrosine kinase. It was developed by Chugai Pharmaceutical Co. Japan, which is part of the Hoffmann-La Roche group. Alectinib is specifically used in the treatment of non-small cell lung cancer (NSCLC) expressing the ALK-EML4 (echinoderm microtubule-associated protein-like 4) fusion protein that causes proliferation of NSCLC cells. Inhibition of ALK prevents phosphorylation and subsequent downstream activation of STAT3 and AKT resulting in reduced tumour cell viability. Approved under accelerated approval in 2015, alectinib is indicated for use in patients who have progressed on or were not tolerant of crizotinib, which is associated with the development of resistance. Alectinib is marketed as Alecensa. — NCATS

Clinical trial activity

59 trials · 54 clinical orgs · 1 marketing orgs

Phase 1
17
Phase 2
40
Phase 3
12
Phase 4
1

Earliest trial started Apr 1, 2012 (NCT01588028)

Timeline

2010s

  1. Jan 1, 2012

    Roche — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2013

    Roche — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2014

    Roche — Earliest Phase 3 Sponsor(trial)

  4. Jan 27, 2015

    Orphan Drug Designation

  5. Dec 11, 2015

    Roche — Earliest FDA Approval

  6. Dec 11, 2015

    Roche — NDA Organization

  7. Dec 11, 2015

    Roche — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedBreakthroughDec 11, 2015

Chemistry & pharmacology

Loading structure…

SMILES

CCc1cc2c(cc1N1CCC(N3CCOCC3)CC1)C(C)(C)c1[nH]c3cc(C#N)ccc3c1C2=O
Mol. weight
482.63 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 9-ethyl-6,6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-6,11-dihydro-5h-benzo[b]carbazole-3-carbonitrile
  • 9-ethyl-6,6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-6,11-dihydro-5h-benzo[b]carbazole-3-carbonitrile
  • af-802
  • af-802
  • alecensa
  • alecensa
  • alecensa
  • alectinib
  • alectinib
  • alectinib
  • alectinib
  • alectinib
  • alectinib
  • alectinib
  • alectinib
  • alectinib
  • alectinib
  • alectinib hcl
  • alectinib hydrochloride
  • alectinib hydrochloride
  • alectinib hydrochloride
  • alectinib hydrochloride
  • alectinib hydrochloride
  • ch5424802
  • ch5424802
  • ch5424802
  • ch5424802
  • ch-5424802
  • ch-5424802
  • ro5424802
  • ro5424802
  • ro5424802
  • ro5424802
  • ro-5424802
  • ro5452802

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07001384Phase 1Aug 8, 2025Genentech, Memorial Sloan-Kettering Cancer Center, Secura
NCT06765109Phase 3Jul 17, 2025Nuvalent Inc.
NCT06692491Phase 2Jan 1, 2025Peking University
NCT06624059Phase 2Dec 20, 2024Roche
NCT06709274N/ANov 30, 2024Government of China, Guangdong Association of Clinical Trials, Shantou University
NCT06322095Phase 2Mar 22, 2024Suzhou Genhouse Bio Co., Ltd.
NCT05987956Phase 2/Phase 3 (Phase 3)Mar 8, 2024Medicine Invention Design, Inc
NCT05987644Phase 1/Phase 2 (Phase 2)Dec 31, 2023Genentech, Hoosier Cancer Research Network, Ohio State University
NCT05770037Phase 2/Phase 3 (Phase 3)Oct 31, 2023Cancer Research UK, Roche, Royal Marsden Hospital NHS Trust, The Christie NHS Foundation Trust, University of Birmingham, University of Manchester
NCT05722886Phase 2/Phase 3 (Phase 3)Mar 1, 2023Cancer Research UK, Roche, Royal Marsden Hospital NHS Trust, The Christie NHS Foundation Trust, University of Birmingham, University of Manchester
NCT05238831Phase 2Dec 1, 2022Genentech, OHSU Knight Cancer Institute, Oregon Health and Science University
NCT05170204Phase 3Nov 1, 2022Roche
NCT05725200Phase 2Sep 27, 2022University of Oslo
NCT05713006Phase 1/Phase 2 (Phase 2)May 1, 2022Government of Mexico
NCT05525338Phase 4Mar 23, 2022Erasmus University Rotterdam, Leiden University, Maastricht University, Netherlands Cancer Institute, Radboud University, University of Amsterdam, University of Groningen
NCT06354387Phase 1Feb 16, 2022China Medical University
NCT04774718Phase 1/Phase 2 (Phase 2)Dec 31, 2021Roche
NCT05159245Phase 2Dec 10, 2021University of Helsinki
NCT05015010Phase 2May 20, 2021Gruppo Oncologico Italiano di Ricerca Clinica
NCT04644315Phase 2Jan 4, 2021Roche
Showing 20 of 59 trials
Page 1 / 3

Organizations

Research & Development (54)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RocheFor profit322342012
GenentechFor profit10432014
Harvard UniversityAcademic/Hospital3312015
Cancer Research UKAcademic/Hospital2212023
German Cancer Research CenterAcademic/Hospital2112017
Government of MexicoGovernment2212019
Netherlands Cancer InstituteAcademic/Hospital2022018
Royal Marsden Hospital NHS TrustAcademic/Hospital2012023
The Christie NHS Foundation TrustAcademic/Hospital2012023
University of BirminghamAcademic/Hospital2012023
University of ManchesterAcademic/Hospital2012023
Albert Einstein Israelite HospitalAcademic/Hospital1112020
Ariad PharmaceuticalsFor profit1112018
Central South UniversityAcademic/Hospital1112020
China Medical UniversityAcademic/Hospital1112022
Chinese Academy of Medical SciencesAcademic/Hospital1112020
Deutsche Krebshilfe e.V.Academic/Hospital1012017
Erasmus University RotterdamAcademic/Hospital1012022
European Thoracic Oncology PlatformAcademic/Hospital1112018
Foundation MedicineFor profit1012018
54 organizations
Page 1 / 3

Marketing (2)

OrganizationOrg typeRelationshipDate
RocheFor profitNDADec 11, 2015
RocheFor profitNDA2Dec 11, 2015