ALK Inhibitors Pipeline Drugs Insights Report 2025: Clinical Trials, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies

DelveInsight's "ALK Inhibitors Pipeline Insight 2025" report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in the ALK Inhibitors pipeline landscape. It covers the ALK Inhibitors Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the ALK Inhibitors Pipeline Therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the ALK Inhibitors Pipeline Report

* On 20 October 2025, Nuvalent Inc. announced a Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naive, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).
* DelveInsight's ALK Inhibitors Pipeline report depicts a robust space with 15+ active players working to develop 15+ pipeline therapies for ALK Inhibitors treatment.
* The leading ALK Inhibitors Companies such as Betta Pharmaceuticals, Turning Point Therapeutics, Nuvalent, Roche, LegoChem Biosciences, Pfizer, Qilu Pharmaceutical, Ascentage Pharma, Suzhou Zelgen Biopharmaceuticals, Chia Tai Tianqing Pharmaceutical Group, Beijing Pearl Biotechnology, Novartis and others.
* Promising ALK Inhibitors Therapies such as Neladalkib (NVL-655), Alectinib, Lorlatinib, Ensartinib, Durvalumab, PF-06463922, Brigatinib, TGRX-326, Crizotinib , and others.

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The ALK Inhibitors Pipeline Report provides disease overview, pipeline scenario, and therapeutic assessment of the key pipeline therapies in this domain. The ALK Inhibitors Pipeline Report also highlights the unmet needs with respect to the ALK Inhibitors.

ALK Inhibitors Overview

The anaplastic lymphoma kinase (ALK) receptor is a membrane-bound tyrosine kinase. The pathogenesis of several cancers is closely related to aberrant forms of ALK or aberrant ALK expression, including ALK fusion proteins, ALK-activated point mutations, and ALK amplification. Clinical applications of different ALK inhibitors represent significant progress in targeted therapy. The receptor ALK plays a pivotal role in cellular communication and in the normal development and function of the nervous system. This observation is based on the extensive expression of ALK messenger RNA (mRNA) throughout the nervous system during mouse embryogenesis. In vitro functional studies have demonstrated that ALK activation promotes neuronal differentiation of PC12 or neuroblastoma cell lines.

ALK Inhibitors Emerging Drugs Profile

* Ensartinib: Betta Pharmaceuticals

Ensartinib hydrochloride is a potent and highly selective next-generation ALK inhibitor with independent intellectual property rights, and it is developed jointly by Betta Pharmaceuticals Co., Ltd. and its subsidiary Xcovey Holding, Inc. (Xcovery). Ensartinib hydrochloride is another product following the EGFR-TKI in Betta's lung cancer pipeline, and it is expected to be the first innovative targeted drug for lung cancer which is launched globally by a Chinese company. Currently, it is in phase 3 stage of development for the treatment of Non-small cell lung cancer.

* TPX 0131: Turning Point Therapeutics

TPX-0131 is a next-generation ALK inhibitor entering IND-enabling studies. It has been designed with a novel compact macrocyclic structure and has shown preclinical potent inhibition of wildtype and numerous ALK mutations, including the clinically observed G1202R solvent-front mutation and the G1202R/L1196M compound mutation. Currently, it is in phase 1/2 of development stage for the treatment of Non-small cell lung cancer.

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The ALK Inhibitors Pipeline report provides insights into:-

* The report provides detailed insights about companies that are developing therapies for the treatment of ALK Inhibitors with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for ALK Inhibitors Treatment.
* ALK Inhibitors Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* ALK Inhibitors Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the ALK Inhibitors market.

ALK Inhibitors Companies

Betta Pharmaceuticals, Turning Point Therapeutics, Nuvalent, Roche, LegoChem Biosciences, Pfizer, Qilu Pharmaceutical, Ascentage Pharma, Suzhou Zelgen Biopharmaceuticals, Chia Tai Tianqing Pharmaceutical Group, Beijing Pearl Biotechnology, Novartis and others.

ALK Inhibitors Pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as,

* Infusion
* Intradermal
* Intramuscular
* Intranasal
* Oral
* Parenteral
* Subcutaneous
* Topical.
* Molecule Type

ALK Inhibitors Products have been categorized under various Molecule types, such as,

* Vaccines
* Monoclonal Antibody
* Peptides
* Polymer
* Small molecule
* Product Type

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Scope of the ALK Inhibitors Pipeline Report

* Coverage- Global
* ALK Inhibitors Companies- Betta Pharmaceuticals, Turning Point Therapeutics, Nuvalent, Roche, LegoChem Biosciences, Pfizer, Qilu Pharmaceutical, Ascentage Pharma, Suzhou Zelgen Biopharmaceuticals, Chia Tai Tianqing Pharmaceutical Group, Beijing Pearl Biotechnology, Novartis and others.
* ALK Inhibitors Therapies- Neladalkib (NVL-655), Alectinib, Lorlatinib, Ensartinib, Durvalumab, PF-06463922, Brigatinib, TGRX-326, Crizotinib , and others.
* ALK Inhibitors Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* ALK Inhibitors Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents

* Introduction
* Executive Summary
* Anaplastic Lymphoma Kinase (ALK) Inhibitors: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Anaplastic Lymphoma Kinase (ALK) Inhibitors - DelveInsight's Analytical Perspective
* In-depth Commercial Assessment
* Anaplastic Lymphoma Kinase (ALK) Inhibitors Collaboration Deals
* Late Stage Products (Phase III)
* Ensartinib: Betta Pharmaceuticals
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I/II)
* TPX 0131: Turning Point Therapeutics
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* BI-1701963: Boehringer Ingelheim
* Drug profiles in the detailed report.....
* Pre-clinical and Discovery Stage Products
* MRTX-1133: Mirati Therapeutics
* Drug profiles in the detailed report.....
* Inactive Products
* Anaplastic Lymphoma Kinase (ALK) Inhibitors Key Companies
* Anaplastic Lymphoma Kinase (ALK) Inhibitors Key Products
* Anaplastic Lymphoma Kinase (ALK) Inhibitors- Unmet Needs
* Anaplastic Lymphoma Kinase (ALK) Inhibitors- Market Drivers and Barriers
* Anaplastic Lymphoma Kinase (ALK) Inhibitors- Future Perspectives and Conclusion
* Anaplastic Lymphoma Kinase (ALK) Inhibitors Analyst Views
* Anaplastic Lymphoma Kinase (ALK) Inhibitors Key Companies
* Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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