Uveal Melanoma Pipeline Insight 2025: 30+ Pipeline Drugs, Targeted Therapies, and Immuno-Oncology Strategies Drive Innovation | DelveInsight

DelveInsight's "Uveal Melanoma - Pipeline Insight, 2025" explores over 30+ therapies in development for uveal melanoma, a rare and aggressive intraocular malignancy with high metastatic potential, most commonly to the liver. Despite surgery and radiotherapy being standards for localized disease, patients with metastatic uveal melanoma face limited systemic treatment options, creating significant unmet needs in the uveal melanoma treatment landscape.

The uveal melanoma pipeline is diversifying with next-generation targeted therapies, including bispecific T-cell engagers (such as tebentafusp), protein kinase C (PKC) inhibitors, and agents targeting GNAQ/GNA11-driven pathways. Immuno-oncology approaches are advancing as well, with immune checkpoint inhibitors, oncolytic viruses, and adoptive T-cell therapies under active evaluation. In addition, novel small molecules, antibody-drug conjugates, and combination regimens are being investigated to overcome resistance and extend benefits for patients beyond the modest outcomes of current options.

With uveal melanoma clinical trials spanning targeted agents, immunotherapies, and novel biologics, the therapeutic focus is shifting toward precision and immune-driven strategies tailored to the tumor's unique biology. As late-stage candidates advance, the uveal melanoma market is expected to evolve rapidly, moving from a limited-treatment environment to one shaped by innovative mechanisms that could meaningfully extend survival and improve quality of life for patients with this rare and devastating cancer.

Interested in learning more about the current treatment landscape and the key drivers shaping the Uveal Melanoma pipeline? Click here: https://www.delveinsight.com/report-store/uveal-melanoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Uveal Melanoma Pipeline Report
• DelveInsight's Uveal Melanoma pipeline analysis depicts a strong space with 25+ active players working to develop 30+ pipeline drugs for Uveal Melanoma treatment.
• The leading Uveal Melanoma companies include Novartis Pharmaceuticals, Foghorn Therapeutics, TriSalus Life Sciences, Inc., Bristol Myers Squibb, Array BioPharma, Ono Pharmaceutical, AstraZeneca, Roche, IDEAYA Biosciences, Merck & Co., GlaxoSmithKline, Janssen, and others are evaluating their lead assets to improve the Uveal Melanoma treatment landscape.
• Key Uveal Melanoma pipeline therapies in various stages of development include Binimetinib, BVD-523, Ulixertinib, AU 011, PAC-1, DYP688, Selumetinib, RO7293583, IDE 196, Niraparib, and others.
• In April 2025, IDEAYA Biosciences, Inc. announced a successful FDA Type D meeting regarding the Phase III trial design for darovasertib. The trial aims to assess the safety and efficacy of darovasertib as neoadjuvant therapy for primary uveal melanoma (UM), with potential regulatory approval in sight.
• In March 2025, IDEAYA Biosciences announced that the FDA granted Breakthrough Therapy designation for darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for the neoadjuvant treatment of adult patients with primary uveal melanoma (UM) recommended for enucleation.

Request a sample and discover the recent breakthroughs happening in the Uveal Melanoma pipeline landscape at https://www.delveinsight.com/report-store/uveal-melanoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Uveal Melanoma Overview
Uveal melanoma is the most common primary intraocular cancer in adults, originating from melanocytes within the uveal tract of the eye, which includes the iris, ciliary body, and choroid. It is a rare disease but potentially lethal, especially when it metastasizes - most commonly to the liver. Unlike cutaneous melanoma, uveal melanoma is not strongly linked to UV exposure and has distinct genetic and molecular characteristics, such as mutations in GNAQ, GNA11, BAP1, and others.

Clinically, uveal melanoma may be asymptomatic or present with vision changes, flashes, or floaters, and is typically diagnosed through imaging techniques like ultrasound, OCT, and fundoscopic exams. Treatment for localized disease often involves radiation therapy (such as plaque brachytherapy) or enucleation in more advanced cases. However, metastatic uveal melanoma remains a major challenge, with limited effective systemic treatments to date, though recent advances in targeted therapies and immunotherapy are showing promise.

Find out more about Uveal Melanoma medication at https://www.delveinsight.com/report-store/uveal-melanoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Uveal Melanoma Treatment Analysis: Drug Profile
BVD-523 (Ulixertinib) - BioMed Valley Discoveries, Inc
BVD-523, also known as ulixertinib, is a novel targeted cytotoxic agent developed to inhibit ERK, a key component of the MAPK signaling pathway. It is being explored as a treatment for cancers driven by mutations in this pathway. By using BVD-523 alone or in combination with other therapies, it may offer a promising approach for treating malignancies characterized by abnormal MAPK activity. Currently, BVD-523 is in Phase II clinical development for the treatment of uveal melanoma.

AU-011 - Aura Biosciences, Inc
AU-011 is an investigational therapy in Phase II development for uveal melanoma. It is administered into the suprachoroidal (SC) space, which allows for a significantly higher concentration of the drug to reach the tumor site-potentially improving therapeutic outcomes. AU-011 has received both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA), reflecting its potential to address a serious unmet medical need.

PAC-1 - Vanquish Oncology
PAC-1 (Procaspase Activating Compound-1) is currently undergoing Phase I/II clinical trials for uveal melanoma. It functions as an apoptotic and caspase-3 stimulant, targeting the apoptotic pathway-a mechanism often disrupted in cancer cells. By activating caspase-3, PAC-1 promotes cancer cell death, offering a novel mechanism to treat tumors where this pathway is abnormally regulated.

Learn more about the novel and emerging Uveal Melanoma pipeline therapies at https://www.delveinsight.com/report-store/uveal-melanoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Uveal Melanoma Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Subcutaneous
• Intravenous
• Intramuscular

By Molecule Type
• Bispecific Antibody
• Peptides
• Small molecule
• Gene therapy

Scope of the Uveal Melanoma Pipeline Report
• Coverage: Global
• Key Uveal Melanoma Companies: Novartis Pharmaceuticals, Foghorn Therapeutics, TriSalus Life Sciences, Inc., Bristol Myers Squibb, Array BioPharma, Ono Pharmaceutical, AstraZeneca, Roche, IDEAYA Biosciences, Merck & Co., GlaxoSmithKline, Janssen, and others.
• Key Uveal Melanoma Pipeline Therapies: Binimetinib, BVD-523, Ulixertinib, AU 011, PAC-1, DYP688, Selumetinib, RO7293583, IDE 196, Niraparib, and others.

To dive deep into rich insights for drugs used for Uveal Melanoma treatment, visit: https://www.delveinsight.com/report-store/uveal-melanoma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Uveal Melanoma Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Uveal Melanoma Pipeline Therapeutics
6. Uveal Melanoma Pipeline: Late-Stage Products (Phase III)
7. Uveal Melanoma Pipeline: Mid-Stage Products (Phase II)
8. Uveal Melanoma Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve.

This release was published on openPR.