Eton Pharmaceuticals, Inc. announced on September 28, 2026, that it has launched IMPAVIDO (miltefosine) capsules in the United States. The company holds exclusive commercialization rights for the product in the country. As part of the launch, Eton has integrated its full Eton Cares patient support program, which includes a $0 co-pay for eligible commercially insured patients and expanded patient assistance programs.
The company has established centralized distribution through Anovo Specialty Pharmacy to simplify access for outpatient prescribing, inpatient consignment, and urgent access coordination. Hospital pharmacies can establish access through the Anovo network, while patients and providers can contact Anovo directly. The company stated that for urgent or time-sensitive needs, Anovo will coordinate an emergency access pathway with treating clinicians, CDC representatives, and hospital pharmacies.
IMPAVIDO is indicated for adults and adolescents 12 years of age or older weighing at least 30 kg for the treatment of visceral leishmaniasis and cutaneous and mucosal leishmaniasis caused by specific species of Leishmania. The company noted that the efficacy of IMPAVIDO in treating other Leishmania species has not been evaluated.
Important safety information includes contraindications for use during pregnancy, in patients with Sjögren-Larsson syndrome, and in patients with hypersensitivity to miltefosine. The drug carries warnings regarding embryo-fetal toxicity, requiring pregnancy testing before initiation and effective contraception during treatment and for five months after completion. Common adverse reactions include nausea, vomiting, diarrhea, headache, and decreased appetite.
Eton Pharmaceuticals is an innovative pharmaceutical company focused on rare diseases. The company currently has eleven commercial rare disease products, including KHINDIVI, INCRELEX, ALKINDI SPRINKLE, DESMODA, GALZIN, HEMANGEOL, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The company also has five additional product candidates in late-stage development: AMGLIDIA, ASN-001, ET-700, ET-800, and ZENEO hydrocortisone autoinjector.
