Last reviewed · How we verify
ALECTINIB
At a glance
| Generic name | ALECTINIB |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2015 |
Approved indications
Common side effects
- Fatigue
- Edema
- Constipation
- Nausea
- Diarrhea
- Vomiting
- Pneumonia
- Renal impairment
- Hyperbilirubinemia
- Increased AST
- Increased ALT
- Increased alkaline phosphatase
Key clinical trials
- Pharmacogenomics ANDA 221517 SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms (PHASE2, PHASE3)
- Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC (PHASE3)
- Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (PHASE2)
- Alectinib in Combination With Nivolumab in the Treatment of Recurrent or Refractory HCC Patients Guided With Serum RNase1 and Tumor Expression of PD-L1 (PHASE1)
- A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) (PHASE3)
- Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements (PHASE1, PHASE2)
- A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (PHASE2, PHASE3)
- Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ALECTINIB CI brief — competitive landscape report
- ALECTINIB updates RSS · CI watch RSS