DEER PARK, Ill. — September 28, 2026
Eton Pharmaceuticals, Inc. announced the U.S. commercial launch of IMPAVIDO® (miltefosine) capsules, with Eton holding exclusive commercialization rights for the product in the United States. The company has integrated IMPAVIDO into its Eton Cares® patient support program, including a $0 co-pay option for eligible commercially insured patients and expanded patient assistance programs. Distribution is being centralized through Anovo Specialty Pharmacy, with the network designed to support outpatient prescribing, inpatient consignment and urgent access coordination. Eton said the commercial infrastructure is intended to simplify prescription fulfillment and treatment initiation while expanding access to IMPAVIDO for patients who require therapy for specified forms of leishmaniasis.
IMPAVIDO Approved for Multiple Forms of Leishmaniasis
IMPAVIDO is an antileishmanial medicine indicated for adults and adolescents aged 12 years and older who weigh at least 30 kg for specified forms of visceral, cutaneous and mucosal leishmaniasis. The approved indications include visceral leishmaniasis caused by Leishmania donovani, cutaneous leishmaniasis caused by L. braziliensis, L. guyanensis and L. panamensis, and mucosal leishmaniasis caused by L. braziliensis. The prescribing information notes that the Leishmania species evaluated in clinical trials were based on epidemiologic data and that geographic variation may affect response to treatment. Eton’s commercial launch therefore provides a U.S. distribution and support infrastructure for an already approved therapy while maintaining the product’s existing labeled indications and limitations of use.
Eton Expands Patient Support and Distribution
The company’s Eton Cares® program is designed to provide additional financial and logistical support to eligible patients and healthcare providers. Commercially insured eligible patients may qualify for a $0 co-pay, while expanded patient assistance programs are intended to support additional access needs. Healthcare providers can submit prescriptions through Anovo Specialty Pharmacy, which will serve as the centralized distribution channel. Hospital pharmacies can also establish access through Anovo’s hospital network for inpatient use. For urgent or time-sensitive cases, Eton said Anovo will coordinate an emergency access pathway involving treating clinicians, hospital pharmacies and CDC representatives to identify an available product source and delivery option based on the patient’s required treatment timeline and institution location. Eton is also working to expand hospital on-site availability through consignment inventory.
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IMPAVIDO Carries Important Safety Warnings
IMPAVIDO carries a boxed warning for embryo-fetal toxicity and is contraindicated during pregnancy, as well as in patients with Sjögren-Larsson syndrome or hypersensitivity to miltefosine or formulation components. The prescribing information recommends pregnancy testing before treatment in females of reproductive potential and effective contraception during treatment and for five months after completion. Additional warnings include potential renal and hepatic effects, gastrointestinal reactions, thrombocytopenia and Stevens-Johnson syndrome, with monitoring requirements specified in the prescribing information. Common adverse reactions include nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, pruritus, somnolence and elevated transaminases or serum creatinine. Eton said the commercial launch expands its rare-disease infrastructure, with IMPAVIDO joining its portfolio of marketed products and additional candidates in late-stage development.
Source Eton Pharmaceuticals,, press release
