Lorbrena

(Lorlatinib)

ApprovedSmall molecule

Lorbrena is a small molecule that works as ALK Tyrosine Kinase Receptor Inhibitor; EML4-ALK Inhibitor.[2] It is being used across 13 indications, with its most advanced program in Approved.[1]

Lorbrena is one of 368 small molecule programs targeting Glioma. It is currently in Approved.

Indications

Total Trials

Active Trials

367

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

GliomaActive, not recruiting

MetastasisActive, not recruiting

Erectile DysfunctionActive, not recruiting

Lung CancerActive, not recruiting

Anaplastic Large Cell LymphomaApproved

LymphomaActive, not recruiting

NeuroblastomaActive, not recruiting

Kidney DiseaseApproved

Lung AdenocarcinomaActive, not recruiting

Liver DiseaseApproved

GliomaPhase 1

Active, not recruiting

MetastasisPhase 2

Active, not recruiting

Erectile DysfunctionPreclinical

Active, not recruiting

Lung CancerPhase 2

Active, not recruiting

Anaplastic Large Cell LymphomaApproved

Approved

LymphomaPhase 2

Active, not recruiting

NeuroblastomaPreclinical

Active, not recruiting

Kidney DiseaseApproved

Approved

Lung AdenocarcinomaPhase 3

Active, not recruiting

Liver DiseaseApproved

Approved

Showing 10 of 13 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Lorbrena

Pfizer

Approved

1 2

Oncaspar

SServier

Preclinical

15 3

Norvir

AbbVie

Preclinical

1 4

Wellcovorin

GGlaxo Dba Glaxosmithkline

Preclinical

4 5

Tafasitamab

Incyte

Preclinical

7 6

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 7

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 8

Nuvigil

NNuvo Research GmbH

Preclinical

1 9

PEG-Intron

Merck & Co.

Preclinical

1 10

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Recruiting

Erectile Dysfunction

NCT06532149

Q4 2026

Post-ApprovalActive, not recruiting

Lorlatinib

NCT05144997

Q1 2027

Phase 2Active, not recruiting

Lorlatinib

NCT04621188

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT03737994

Post-ApprovalNot yet recruiting

Leptomeningeal Metastases

NCT06282874

Q2 2027

Phase 2Not yet recruiting

Non-Small Cell Lung Cancer

NCT06682884

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer15 trials

Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer

Not yet recruiting·PPeking University People's Hospital·Phase 2·NCT06682884·25 enrolled

Explore the Mechanisms Underlying Disease Resistance and Potential Primary Resistance Mechanism of Induction Therapy Lorlatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Positive Mutation Revealed by Single-cell RNA Sequencing and Spatial Transcriptomics

Not yet recruiting·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 4·NCT06893354·20 enrolled

Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer

Completed·IIntergroupe Francophone de Cancerologie Thoracique·Phase 2·NCT04111705·23 enrolled

Show 12 more trials

Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer

Completed· Pfizer logo

Pfizer·Phase 4·NCT04362072·71 enrolled

Enrolling by invitation·PPeking University Third Hospital··NCT06876675·167 enrolled

Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07415005·30 enrolled

A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib

Recruiting·CCentro di Riferimento Oncologico - Aviano·Phase 2·NCT06378892·45 enrolled

Lorlatinib in Combination With Chemotherapy in Participants With Metastatic Anaplastic Lymphoma Kinase Positive (ALK+) Non-small Cell Lung Cancer (NSCLC) Who Progressed on Single-agent Lorlatinib

Withdrawn·SSCRI Development Innovations, LLC·Phase 2·NCT05948462

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

Completed· Pfizer logo

Pfizer··NCT05834348·5,279 enrolled

A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors

Completed· Takeda logo

Takeda··NCT03546894·111 enrolled

Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03737994·10 enrolled

Induction Lorlatinib in Stage III Non-small Cell Lung Cancer

Active, not recruiting·GGuangdong Provincial People's Hospital·Phase 2·NCT05740943·48 enrolled

A Study of Lorlatinib in Subjects With ROS1-Positive Non-Small Cell Lung Cancer

Active, not recruiting·CCStone Pharmaceuticals·Phase 2·NCT05297890·70 enrolled

A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled

Completed· Pfizer logo

Pfizer··NCT06282991·73 enrolled

A Phase 1/2 Study of Combination Lorlatinib and Ramucirumab in Patients With Advanced ALK-rearranged Lung Cancers

Recruiting·MMemorial Sloan Kettering Cancer Center·Preclinical·NCT06007937·56 enrolled

Lorlatinib9 trials

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT03052608·296 enrolled

Lorlatinib Continuation Study

Active, not recruiting· Pfizer logo

Pfizer·Phase 4·NCT05144997·76 enrolled

A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction

Completed· Pfizer logo

Pfizer·Phase 1·NCT05224609·21 enrolled

Show 6 more trials

A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China

Completed· Pfizer logo

Pfizer·Phase 2·NCT03909971·109 enrolled

NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)

Completed·NNew Approaches to Neuroblastoma Therapy Consortium·Phase 1·NCT03107988·65 enrolled

Single-dose Study of [14C]Lorlatinib (PF-06463922) Metabolism In Healthy Male Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT03184168·6 enrolled

Study of Lorlatinib in ROS1 Rearranged NSCLC

Unknown status·NNational Cancer Center, Korea·Phase 2·NCT03612154·35 enrolled

Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS)

Active, not recruiting·IIntergroupe Francophone de Cancerologie Thoracique·Phase 2·NCT04621188·54 enrolled

Lorlatinib - PF-06463922

Approved for marketing· Pfizer logo

Pfizer··NCT03127618

Lung Cancer3 trials

PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer

Unknown status·FFondazione Ricerca Traslazionale·Phase 2·NCT03439215·20 enrolled

Lorlatinib Combinations in Lung Cancer

Unknown status·MMassachusetts General Hospital·Phase 1/2·NCT04292119·96 enrolled

A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions

Unknown status·MMassachusetts General Hospital·Phase 2·NCT02927340·30 enrolled

Neuroblastoma2 trials

Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib

Terminated· Pfizer logo

Pfizer··NCT04753658·15 enrolled

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

Recruiting·CChildren's Oncology Group·Phase 3·NCT03126916·750 enrolled

Trial2 trials

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

19 more indications

Metastasis2 trials

A Retrospective Study of the Efficacy and Safety of Lolatinib in ALK+ NSCLC Patients With Brain or Meningeal Metastasis

Active, not recruiting·SSichuan Cancer Hospital and Research Institute··NCT06410040·28 enrolled

Lorlatinib in ROS1+ NSCLC With Brain Metastasis

Not yet recruiting·HHunan Cancer Hospital·Phase 2·NCT07083687·21 enrolled

Small Cell Lung Cancer2 trials

Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India

Completed· Pfizer logo

Pfizer·Phase 4·NCT04541706·100 enrolled

Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

No longer available· Pfizer logo

Pfizer··NCT03178071

Real-world Study1 trial

Real-world Study of Local Therapy Changes During 1L Lorlatinib in Unresectable ALK+ NSCLC

Not yet recruiting·PPeking University Cancer Hospital & Institute··NCT06690541·100 enrolled

Erectile Dysfunction1 trial

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Recruiting·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT06532149·80 enrolled

Advanced Solid Tumors1 trial

PF-07284892 in Participants With Advanced Solid Tumors

Terminated· Pfizer logo

Pfizer·Phase 1·NCT04800822·53 enrolled

Tyrosine Kinase Inhibitor1 trial

Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.

Completed· Pfizer logo

Pfizer··NCT04647110·549 enrolled

Advanced1 trial

Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients

Recruiting·SSichuan Cancer Hospital and Research Institute··NCT06361589·200 enrolled

Metastatic NSCLC1 trial

Efficacy & Safety Study of Lorlatinib in ALK/ROS1 Metastatic NSCLC Patients With Compassionate Use Treatment

Completed·FFundación GECP··NCT05167500·118 enrolled

Leptomeningeal Metastases1 trial

Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases

Not yet recruiting·GGuangdong Association of Clinical Trials·Phase 4·NCT06282874·50 enrolled

Lymphoma1 trial

A Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma

Unknown status·UUniversity of Milano Bicocca·Phase 2·NCT03505554·12 enrolled

Single Dose1 trial

Effect of Multiple Doses of Modafinil on the Pharmacokinetics of Single Dose Lorlatinib in Healthy Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT03961997·16 enrolled

ALK Positive1 trial

Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients

Active, not recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT04127110·68 enrolled

Lung Adenocarcinoma1 trial

Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma

Not yet recruiting·GGuangdong Association of Clinical Trials·Phase 3·NCT06858410·36 enrolled

Hepatic Impairment1 trial

Hepatic Impairment Study for Lorlatinib in Cancer Patients

Terminated· Pfizer logo

Pfizer·Phase 1·NCT03726333·1 enrolled

Effectiveness1 trial

Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context

Recruiting· Pfizer logo

Pfizer·N/A·NCT06487078·90 enrolled

Renal Impairment1 trial

Lorlatinib Renal Impairment Study

Completed· Pfizer logo

Pfizer·Phase 1·NCT03542305·29 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

A RETROSPECTIVE STUDY TO EVALUATE THE REAL-WORLD EFFECTIVENESS OF LORLATINIB AMONG ROS1-POSITIVE NSCLC PATIENTS

Completed· Pfizer logo

Pfizer··NCT06678555·22 enrolled

High Grade Glioma1 trial

A Pilot Study of Lorlatinib for Treatment of Children With Newly Diagnosed High-Grade Glioma With ROS-1 (ROS Proto-Oncogene 1, Receptor Tyrosine Kinase) or ALK (Anaplastic Lymphoma Kinase) Fusion

Recruiting·NNationwide Children's Hospital·Phase 1·NCT06333899·15 enrolled

Unspecified1 trial

StrataPATH™ (Precision Indications for Approved Therapies)

Terminated·SStrata Oncology·Phase 2·NCT05097599·11 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 2, 2018

LORBRENA

NDA NDA210868

Sources

References

[1]
ClinicalTrials.gov — 52 trial records for Lorlatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lorlatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lorlatinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210868). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Lorbrena. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: ALK Tyrosine Kinase Receptor Inhibitor; EML4-ALK Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Pfizer

Patent Landscape[5]

Patent Cliff

Mar 5, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8680111Mar 5, 2033

10420749Jul 27, 2036

11020376Jul 27, 2036

11299500Oct 4, 2038

Lorbrena

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer15 trials

Lorlatinib9 trials

Lung Cancer3 trials

Neuroblastoma2 trials

Trial2 trials

Metastasis2 trials

Small Cell Lung Cancer2 trials

Real-world Study1 trial

Erectile Dysfunction1 trial

Advanced Solid Tumors1 trial

Tyrosine Kinase Inhibitor1 trial

Advanced1 trial

Metastatic NSCLC1 trial

Leptomeningeal Metastases1 trial

Lymphoma1 trial

Single Dose1 trial

ALK Positive1 trial

Lung Adenocarcinoma1 trial

Hepatic Impairment1 trial

Effectiveness1 trial

Renal Impairment1 trial

Carcinoma, Non-Small-Cell Lung1 trial

High Grade Glioma1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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