Uveal Melanoma Pipeline Summary

DelveInsight’s, “Uveal Melanoma - Pipeline Insight, 2026” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Uveal Melanoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Uveal Melanoma: Understanding

Uveal Melanoma: Overview

Uveal melanoma is a rare but the most common noncutaneous melanoma and primary intraocular malignancy in adults. It predominantly affects older adults, with a slight male predominance, and occurs most frequently among Caucasian populations. The choroid is the primary site of origin in most cases, while the ciliary body and iris are less commonly involved. Although its etiology remains unclear, light skin and eye color, chronic sunlight exposure, and pre-existing uveal nevi have been proposed as potential risk factors. However, molecular evidence does not demonstrate the typical UV-associated mutational profile observed in cutaneous melanoma, suggesting that any role of light exposure may involve different mechanisms. Uveal nevi are relatively common in Caucasian populations,

although only a small proportion are thought to undergo malignant transformation into uveal melanoma.

Several risk factors have been associated with uveal melanoma (UM), including light-colored eyes, fair skin, poor tanning ability, ocular melanocytosis, dysplastic nevus syndrome, and BAP1 mutations. BAP1 is a tumor-suppressor gene located on chromosome 3 and is frequently altered in UM. Germline BAP1 mutations are associated with earlier-onset disease and may increase susceptibility to additional malignancies, including cutaneous melanoma and renal cell carcinoma. The role of sunlight exposure remains uncertain, as studies have reported inconsistent associations between UV exposure and UM risk; however, factors such as extensive outdoor exposure, tanning, limited ocular sun protection, and welding have been linked to increased risk in some studies. Emerging evidence also suggests that light eye color and sunlight exposure may independently contribute to distinct anatomical and molecular subtypes of UM.

Unlike cutaneous melanoma, uveal melanoma (UM) is characterized by a relatively limited number of genetic alterations, with GNAQ and GNA11 mutations serving as major molecular drivers. These mutations cause constitutive G-protein signaling and activate downstream MAPK, PI3K–AKT–mTOR, and Hippo pathways, promoting tumor-cell proliferation, survival, and growth. GNAQ and GNA11 alterations are generally mutually exclusive, while less frequent mutations in PLCB4 and CYSLTR2 can activate similar signaling mechanisms, further supporting the importance of G? signaling in UM. Constitutive G? activation stimulates phospholipase C and PKC, triggering the RAF–MEK–ERK cascade, while PI3K–AKT–mTOR functions as a parallel growth pathway and may contribute to resistance following MAPK inhibition. Hippo pathway activation through YAP and TAZ further supports tumor proliferation and survival, providing multiple potential therapeutic targets and a rationale for combination treatment strategies in advanced disease. In addition to G? signaling alterations, genes involved in transcription, DNA repair, RNA splicing, and translation are frequently altered, particularly BAP1, SF3B1, and EIF1AX. Loss-of-function mutations in BAP1, a tumor-suppressor gene, are associated with aggressive disease and poorer outcomes, whereas SF3B1 alterations are generally linked to more favorable primary tumor characteristics but may be associated with delayed metastasis; EIF1AX mutations are also associated with less metastatic disease. Epigenetic mechanisms, including DNA methylation, histone modification, and dysregulated microRNAs, further contribute to UM development and progression by altering tumor-suppressor and oncogenic pathways. These molecular and epigenetic abnormalities collectively influence tumor growth, invasion, metastatic potential, and clinical outcomes, while providing potential avenues for targeted therapeutic intervention.

Uveal melanoma (UM) management is individualized based on tumor size and location, ocular characteristics, fellow-eye status, systemic health, and patient preferences. Treatment options include transpupillary thermotherapy (TTT), plaque brachytherapy, charged-particle irradiation, stereotactic radiotherapy (SRT), local resection, enucleation, and orbital exenteration. TTT is mainly used for small, flat tumors and may be combined with plaque radiotherapy or used for recurrent disease, although recurrence risk requires careful selection and monitoring. Radiotherapy is the most widely used eye-conserving approach, with plaque brachytherapy commonly selected according to tumor characteristics, while charged-particle irradiation and SRT provide alternatives for tumors unsuitable for plaque treatment. Despite effective local control, radiotherapy can cause complications such as radiation retinopathy, optic neuropathy, maculopathy, cataract, glaucoma, retinal detachment, and vision loss. Enucleation is generally reserved for large or extensively invasive tumors or when eye-conserving treatment is unsuitable, while local resection can preserve the eye but is technically challenging and associated with complications such as retinal detachment and vitreous hemorrhage.

"Uveal Melanoma- Pipeline Insight, 2026" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Uveal Melanoma pipeline landscape is provided which includes the disease overview and Uveal Melanoma treatment guidelines. The assessment part of the report embraces, in depth Uveal Melanoma commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Uveal Melanoma collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Uveal Melanoma R&D. The therapies under development are focused on novel approaches to treat/improve Uveal Melanoma.

Uveal Melanoma Emerging Drugs Chapters

This segment of the Uveal Melanoma report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Uveal Melanoma Emerging Drugs

Belzupacap sarotalocan: Aura Biosciences

Belzupacap sarotalocan is an investigational, first-in-class virus-like drug conjugate (VDC) being developed by Aura Biosciences as a potentially vision-preserving, first-line treatment for early-stage choroidal melanoma, the most common form of uveal melanoma. The therapy is designed to selectively bind tumor cells and, following laser photoactivation, induce targeted tumor-cell necrosis while stimulating an immune response against the tumor. It is administered into the suprachoroidal space using a microinjector and activated with a laser, offering a noninvasive, eye-conserving approach compared with radiotherapy. Bel-sar has progressed to a Phase III Compass trial for the treatment of Uveal Melanoma.

Roginolisib: Ionctura

Roginolisib (IOA-244) is an investigational, oral, first-in-class allosteric modulator of PI3K? being developed by iOnctura for advanced/metastatic uveal melanoma (UM). By selectively modulating PI3K?, roginolisib is designed to exert a dual antitumor effect by directly inhibiting tumor-cell survival while enhancing antitumor immunity through modulation of regulatory and cytotoxic T cells and reduction of immunosuppression. Roginolisib is currently being evaluated in the randomized Phase II OCULE-01 trial as oral monotherapy versus investigator’s choice in patients with advanced/metastatic UM, including those previously treated with immunotherapy but according to company’s pipeline the therapy is in Phase II/III stage of its development for the treatment of uveal melanoma.

DYP688: Novartis

DYP688 is an investigational antibody-drug conjugate (ADC) administered intravenously that selectively targets uveal melanoma cells harboring activating GNAQ or GNA11 mutations by delivering a potent G?q/11 inhibitor directly into the tumor. It consists of an antibody directed against PMEL17 on melanoma cells linked to a cytotoxic payload that inhibits the oncogenic GNAQ/GNA11 signaling pathway, which is a key driver of tumor growth in uveal melanoma. By blocking GNAQ/GNA11-mediated signaling, DYP688 can suppress tumor cell proliferation and induce anti-tumor activity. This novel targeted approach is currently being evaluated in a Phase I/II clinical trial in patients with metastatic uveal melanoma and other GNAQ/11-mutant melanomas to assess safety, tolerability, and preliminary efficacy.

ONM-501: Onconano Medicine

ONM-501 is an investigational, dual-activating STING agonist being developed by OncoNano Medicine for the treatment of advanced solid tumors, including recurrent uveal melanoma (UM). It combines the endogenous STING agonist cGAMP with OncoNano’s proprietary pH-sensitive OMNI polymer, enabling tumor-localized delivery and prolonged STING activation. By stimulating the STING pathway, ONM-501 is designed to activate dendritic cells, promote antigen presentation, enhance cytotoxic T-cell responses, and generate both innate and adaptive antitumor immunity. ONM-501 is being evaluated through intratumoral administration as monotherapy and in combination with the PD-1 inhibitor cemiplimab in the Phase I ON-5001 trial, which includes patients with recurrent UM.

Early clinical data reported disease control lasting more than a year in a patient with recurrent, immunotherapy-exposed UM, supporting further investigation of the approach.

Further product details are provided in the report……..

Uveal Melanoma: Therapeutic Assessment

This segment of the report provides insights about the different Uveal Melanoma drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Uveal Melanoma
• There are approx. 20+ key companies which are developing the therapies for Uveal Melanoma. The companies which have their Uveal Melanoma drug candidates in the most advanced stage, i.e. Phase III include, Aura Biosciences.
• Phases

DelveInsight’s report covers around 25+ products under different phases of clinical development like

• 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
• Route of Administration

Uveal Melanoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Uveal Melanoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Uveal Melanoma therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Uveal Melanoma drugs.

Uveal Melanoma Report Insights

• Uveal Melanoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Uveal Melanoma Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Uveal Melanoma drugs?
• How many Uveal Melanoma drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Uveal Melanoma?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Uveal Melanoma therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Uveal Melanoma and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Aura Biosciences
• IDEAYA Biosciences
• Servier
• Ionctura
• Replimune Inc.
• Immatics US, Inc
• InxMed (Shanghai) Co., Ltd.
• Iovance Biotherapeutics, Inc
• Novartis
• Novelty Nobility, Inc.
• Onconano Medicine
• RebioPharma
• Beijing BioTech
• MonTa Biosciences ApS
• VM Discovery, Inc.

Key Products

• Belzupacap Sarotalocan
• Darovasertib
• Roginolisib
• RP2
• IMA203
• IN10018
• DYP688
• IOV-3001
• NN3201
• ONM-501
• RBP-01
• EB-DTKN-401
• MBS8
• VMD-102