Eton Pharmaceuticals Secures U.S. Commercialization Rights to IMPAVIDO from Knight Therapeutics

Continuity of supply for the only FDA-approved oral therapy for leishmaniasis in the U.S. now shifts to Eton Pharmaceuticals, whose supply and distribution agreement with a Knight Therapeutics affiliate takes effect September 26, 2026. For QA directors and supply chain leads managing rare disease procurement, the transition date is the immediate planning checkpoint.

IMPAVIDO® (miltefosine) carries orphan drug designation and is indicated for visceral, cutaneous, and mucosal leishmaniasis caused by specific Leishmania species in patients aged 12 and older weighing at least 30 kg. The drug has been commercially available in the U.S. since 2016, and the agreement transfers U.S. commercialization responsibilities without altering the approved indication or formulation.

Leishmaniasis is transmitted through infected sand fly bites and presents across a clinical spectrum: cutaneous forms produce skin lesions, mucosal forms affect the upper respiratory tract, and visceral leishmaniasis involves internal organs with potentially fatal outcomes if untreated. The patient population is small, geographically dispersed, and heavily dependent on specialty distribution channels, which places particular weight on transition planning between outgoing and incoming commercial partners.

Eton's model centers on orphan and rare disease commercialization, and the IMPAVIDO® acquisition follows a pattern of portfolio consolidation the company has pursued through 2025 and into 2026. For hospital pharmacists and specialty distributors currently sourcing miltefosine, confirming supply agreements and contract terms ahead of the September cutover will be the near-term operational priority.

The agreement also carries a standard REMS-adjacent safety profile consideration: miltefosine is contraindicated in pregnancy and requires confirmed negative pregnancy testing before initiation, with mandatory contraception through five months post-treatment. Any distributor or institutional pharmacy onboarding IMPAVIDO® under the new commercial arrangement will need to verify that patient support and risk communication infrastructure transfers intact from Knight's affiliate.

The measurable outcome to track is uninterrupted patient access through and beyond the September 26 transition, with no reportable supply gaps in specialty pharmacy channels.

Source: Eton Pharmaceuticals via GlobeNewswire, May 19, 2026.