Data updated: May 26, 2026
ALECENSA (alectinib hydrochloride)
Genetically Validated
Trial Activity: Growth 26 active trials
Oncology
Approved 2015-12-11
Alecensa is a kinase inhibitor used for adults with non-small cell lung cancer that tests positive for anaplastic lymphoma kinase (ALK). It helps patients who have undergone surgery to remove tumors that are 4 cm or larger or have spread to the lymph nodes. Additionally, it treats patients whose ALK-positive lung cancer has reached a metastatic stage.
Source: FDA Label • Roche
How ALECENSA Works
This drug works by targeting and inhibiting the ALK and RET proteins to block the signaling pathways that allow cancer cells to grow. By stopping ALK phosphorylation and the activation of downstream proteins like STAT3 and AKT, it decreases the viability of tumor cells. It remains effective against various mutant forms of the ALK enzyme and has shown the ability to target tumors that have spread to the brain.
Development Insights
Hoffmann-La Roche conducting 19 trials (40%)
87 indications explored (Broad Platform)
→ non-small cell lung cancer (13 trials)
→ neoplasms (4 trials)
→ cancer (4 trials)
3
Indications
--
Phase 3 Trials
3
Priority Reviews
10
Years on Market
Details
- Status
- Prescription
- First Approved
- 2015-12-11
- Patent Cliff
- 2035
- Revenue
- $439M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ALECENSA Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2015 to 2024 · 2 indication expansions
What ALECENSA Treats
1 indicationsALECENSA is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
Source: FDA Label
ALECENSA Target & Pathway
ProTarget
ALECENSA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
8
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
10
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 22 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ALECENSA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ALECENSA treats. First-in-class if their pivotal trials read out positive.
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Uliledlimab TJ004309
TJ Biopharma Co., Ltd. NT5E · monoclonal antibody (anti-CD73) · 1 Phase 3 trial
Drugs Similar to ALECENSA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
48 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07560410 | CMUH115-REC2-048 | Ph 1, Ph 2 | not yet recruiting | Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa) |
| NCT03202940 | 17-112 | Ph 1, Ph 2 | active not recruiting | A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC |
| NCT04589845 | BO41932 2020-001847-16, 2023-507418-28-00 | Ph 2 | active not recruiting | Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study |
| NCT05170204 HORIZON 1 | BO42777 2023-503920-14-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) |
| NCT06765109 ALKAZAR | NVL-655-04 2024-517553-26 | Ph 3 | recruiting | Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC |
| NCT04774718 | GO42286 2020-004239-25 | Ph 1, Ph 2 | recruiting | A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors |
| NCT02314481 DARWINII | 14/0274 | Ph 2 | completed | Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity |
| NCT03768063 IMbrella B | BO40729 2023-506184-34-00 | Ph 3 | active not recruiting | A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study |
| NCT04116541 MegaMOST | ET19-073 (MegaMOST) 2023-510567-35-00, 2019-001494-88 | Ph 2 | recruiting | A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. |
| NCT03737994 results posted | NCI-2018-02486 NCI-2018-02486, NRG-LU003 | Ph 2 | terminated | Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer |
| NCT06624059 HORIZON 2 | BO43249 | Ph 1, Ph 2 | active not recruiting | A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC) |
| NCT07001384 | 25-056 | Ph 1 | recruiting | A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL) |
| NCT05987644 DURABLE | HCRN-LUN21-534 | Ph 1, Ph 2 | recruiting | Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements |
| NCT04302025 | ML41591 | Ph 2 | recruiting | A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC) |
| NCT02838420 results posted | YO29449 | Ph 3 | active not recruiting | 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) |
| NCT03178552 B-FAST | BO29554 2017-000076-28 | Ph 2, Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) |
| NCT03194893 | BO39694 2017-000207-24 | Ph 3 | active not recruiting | A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer |
| NCT05722886 DETERMINE | CRUKD/21/004 IRAS ID: 1004057 | Ph 2, Ph 3 | recruiting | DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol |
| NCT05770037 DETERMINE | CRUKD/21/004 - Treatment Arm 1 IRAS ID: 1004057 | Ph 2, Ph 3 | recruiting | DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers |
| NCT03498521 CUPISCO results posted | MX39795 2017-003040-20 | Ph 2 | completed | A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site |
| NCT03596866 ALTA-3 results posted | Brigatinib-3001 2018-001957-29 | Ph 3 | completed | A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer |
| NCT04341181 ProTarget | ProTarget | Ph 2 | recruiting | ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling |
| NCT02075840 ALEX results posted | BO28984 2013-004133-33 | Ph 3 | completed | A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants |
| NCT02521051 results posted | 15-055 | Ph 1, Ph 2 | terminated | Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer |
| NCT03445000 ALERT-lung results posted | ETOP 12-17 2017-002063-17, MO30176 | Ph 2 | terminated | ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer |
| NCT03944772 ORCHARD | D6186C00001 2023-504624-25-00, 2018-003974-29 | Ph 2 | active not recruiting | Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) |
| NCT04632992 MyTACTIC results posted | ML42439 | Ph 2 | completed | A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response |
| NCT04551521 | NCT-PMO-1602 | Ph 2 | completed | CRAFT: The NCT-PMO-1602 Phase II Trial |
| NCT06692491 SPRING | PUShenzhenH RE [2024]No.(117) | Ph 2 | not yet recruiting | Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS |
| NCT05015010 ALNEO | GOIRC-01-2020 | Ph 2 | active not recruiting | Alectinib in Neo-adjuvant Treatment of Stage III NSCLC |
| NCT02091141 results posted | ML28897 PRO 02 | Ph 2 | completed | My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors |
| NCT05159245 FINPROVE | FINPROVE | Ph 2 | recruiting | The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs |
| NCT05525338 ADAPT ALEC | 202000251 2020-001737-13, NL9411 | Ph 4 | recruiting | Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels |
| NCT02925234 DRUP | M15DRU | Ph 2 | recruiting | The Drug Rediscovery Protocol (DRUP Trial) |
| NCT05081674 BLISS | 4009-19 | Ph 2 | completed | Brazilian Lung Immunotherapy Study |
| NCT03158389 N²M² | NCT-2014-0235/N2M2 2015-002752-27 | Ph 1, Ph 2 | completed | NCT Neuro Master Match - N²M² (NOA-20) |
| NCT04644315 ALpha-T results posted | BO41929 | Ph 2 | terminated | A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors |
| NCT03779191 | Alectinib plus Bevacizumab | Ph 2 | completed | Alectinib in Combination With Bevacizumab in ALK Positive NSCLC |
| NCT05725200 EVIDENT | EVIDENT | Ph 2 | recruiting | Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer |
| NCT03131206 results posted | 17-080 | Ph 1, Ph 2 | terminated | A Study of Alectinib in RET-rearranged Non-small Cell Lung Cancer or RET-mutated Thyroid Cancer |
| NCT02013219 | WP29158 2013-004382-13 | Ph 1 | completed | A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC) |
| NCT03155009 ATALK | ML39349 2016-003924-22 | Ph 2 | completed | A Study of the Efficacy and Safety of Alectinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer |
| NCT02604342 results posted | MO29750 2015-000634-29 | Ph 3 | completed | Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib |
| NCT01801111 results posted | NP28673 2012-004455-36 | Ph 1, Ph 2 | completed | A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment |
| NCT02621047 results posted | NP29783 2015-002976-25 | Ph 1 | completed | Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib |
| NCT01871805 results posted | NP28761 | Ph 1, Ph 2 | completed | A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) |
| NCT01984229 results posted | NP28990 | Ph 1 | completed | A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers |
| NCT02023125 results posted | NP28991 | Ph 1 | completed | A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers. |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ALECENSA FDA Label Details
Indications & Usage
FDA Label (PDF)ALECENSA is indicated for the treatment of Non-Small Cell Lung Cancer.
View full patent landscape →
5 OB patents · 3 families ·
201 international docs across 40 countries
ALECENSA Patents & Exclusivity
Latest Patent: Apr 2035
Exclusivity: Apr 2031
Patents (5 active)
US10350214
Expires Apr 24, 2035
US11433076
Expires Apr 24, 2035
US9365514
Expires Mar 4, 2032
US9126931
Expires May 29, 2031
US9440922
Expires Jun 9, 2030
Exclusivity
I-947
Until Apr 2027
ODE-477
Until Apr 2031
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for ALECENSA
Revenue Insights
- • Q4-2025: $439M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 5 active patents
Trial Analysis
- • 48 total trials
- • Stage: Growth
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment