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Bel-sar

Phase 3

Choroidal Melanoma | Small molecule | Oncology |Aura Biosciences, Inc.|Last Updated: Jul 31, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindSHAM_CONTROLLEDDMC
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

Bel-sar · 1 trial · 4 indications

Phase 3 1
NCT06007690A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal MelanomaChoroidal Melanoma
ACTIVE NOT_RECRUITING108 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
Choroidal MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to reach tumor progression
65 weeks

Tumor Progression

Secondary Endpoints

Time to composite endpoint
65 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
High dose bel-sar treatment arm & laser applicationEXPERIMENTALHigh dose of bel-sar + laser application
Low dose bel-sar treatment arm & laser applicationEXPERIMENTALLow dose of bel-sar + laser application
Sham control arm & sham laserSHAM_COMPARATORSham injection + sham laser

Interventions

NameTypeDescription
Bel-sarDRUGBel-sar via suprachoroidal administration followed by laser application.
Suprachoroidal MicroinjectorDEVICESuprachoroidal injection device
Infrared LaserDEVICELaser application
Sham Infrared LaserDEVICESham laser application
Sham MicroinjectorDEVICESham injection device
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites66

Inclusion Criteria: * Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM) * Have no evidence of metastatic disease confirmed by imaging * Be treatment naive for IL/CM (subjects who received PDT may be eligible) Exclusion Criteria: * Have known contraindications ...

Countries:United StatesAustraliaAustriaBelgiumCanadaCzechiaFranceGermanyIsraelItalyNetherlandsNew ZealandSpainUnited Kingdom
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Recent Changes (Last 90 Days)

MEDIUMJul 31, 2026NCT06007690Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 31, 2026NCT06007690Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about Bel-sar

What is Bel-sar used for?

Bel-sar, also known as belzupacap sarotalocan or AU-011, is an investigational small molecule being developed for the treatment of choroidal melanoma, including primary indeterminate lesions and small choroidal melanoma. It is also being studied for related conditions such as uveal melanoma and ocular melanoma.

What does Bel-sar target?

Bel-sar is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for its efficacy and safety in treating choroidal melanoma, a type of eye cancer, though the exact mechanism of action is not publicly detailed.

Who makes Bel-sar?

Bel-sar is being developed by Aura Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AURA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with choroidal melanoma.

What phase is Bel-sar in?

Bel-sar is currently in Phase 3 clinical development. It is being evaluated in a randomized, double-blind, sham-controlled trial for the treatment of primary indeterminate lesions or small choroidal melanoma. The drug is investigational and has not yet been approved by regulatory authorities.

What clinical trials is Bel-sar in?

Bel-sar is being studied in a Phase 3 clinical trial with the identifier NCT06007690. This trial is a randomized, masked, controlled study comparing Bel-sar treatment to sham control in subjects with primary indeterminate lesions or small choroidal melanoma. The trial is active but not recruiting, with an enrollment of 108 participants.

Is Bel-sar the same as AU-011 or belzupacap sarotalocan?

Yes, Bel-sar is also known as belzupacap sarotalocan and AU-011. These names refer to the same investigational drug being developed by Aura Biosciences for the treatment of choroidal melanoma. The drug is currently in Phase 3 clinical trials.