DEER PARK, Ill., August 5, 2026

Eton Pharmaceuticals has licensed the U.S. rights to ASN-001 (timolol topical gel) from Auson Pharmaceuticals, expanding its leadership in the infantile hemangioma treatment market. The late-stage product candidate is being developed for proliferating superficial infantile hemangiomas, targeting a significantly larger patient population currently treated off-label with ophthalmic timolol products. The acquisition complements HEMANGEOL® (propranolol hydrochloride oral solution), positioning Eton to potentially provide FDA-approved therapies across the full spectrum of infantile hemangioma severity. The company plans to conduct a bioavailability bridging study, submit a New Drug Application (NDA) during the second half of 2027, and, if approved, launch ASN-001 in 2028.

Late-Stage Trial Demonstrated Strong Clinical Efficacy

The licensing agreement is supported by results from a completed Phase II/III clinical trial involving 168 patients, where 56% of patients receiving ASN-001 twice daily achieved elimination or near-elimination of infantile hemangiomas by Week 24, compared with 42% in the three-times-daily treatment group and 15% in the placebo arm. ASN-001 has been specifically formulated as a topical gel for infantile hemangiomas, addressing limitations associated with the widespread off-label use of ophthalmic timolol products, including inconsistent dosing, formulation challenges, and the lack of an FDA-approved topical treatment for this indication. If approved, ASN-001 would become the first FDA-approved topical therapy specifically indicated for infantile hemangiomas, expanding treatment options for infants with moderate disease.

Acquisition Expands Commercial Opportunity in Pediatric Dermatology

According to Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals, the company gained valuable insight into the infantile hemangioma treatment landscape following its acquisition of HEMANGEOL, observing that systemic therapy serves severe cases while a much larger group of patients relies on off-label topical timolol. Infantile hemangiomas affect more than 100,000 infants annually in the United States, with approximately 10,000 to 15,000 patients requiring systemic therapy and an estimated 20,000 to 30,000 patients representing the potential market for an FDA-approved topical treatment such as ASN-001. The company believes the product will leverage its established pediatric dermatology commercial infrastructure, including existing relationships with vascular anomaly centers and specialist physicians already prescribing HEMANGEOL.

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Licensing Agreement Strengthens Eton’s Rare Disease Growth Strategy

The addition of ASN-001 further expands Eton Pharmaceuticals’ rare disease pipeline, adding another late-stage development asset while strengthening the company’s presence in pediatric dermatology. The investigational therapy is protected by patents extending through 2044, with additional patent applications pending, supporting long-term commercial potential. By combining HEMANGEOL for severe cases requiring systemic therapy with ASN-001 for moderate disease, Eton aims to establish a comprehensive treatment portfolio for infantile hemangiomas. The licensing agreement reflects the company’s strategy of acquiring differentiated rare disease products that complement its existing commercial capabilities while addressing significant unmet medical needs in pediatric care.

Source:Eton Pharmaceuticals press release