Stealth BioTherapeutics Inc, a US-based commercial-stage biotechnology company involved in the discovery, development and commercialisation of novel therapies for diseases involving mitochondrial dysfunction, announced on Thursday the launch of its Mito Assist Patient Support Program for access to FORZINITY (elamipretide) injection.

FORZINITY was granted accelerated approval by the US Food and Drug Administration (FDA) on 19 September 2025 as the first treatment for Barth syndrome, to improve muscle strength in adult and paediatric patients weighing at least 30 kg.

As part of this initiative, Stealth says that it has selected AnovoRx Specialty Pharmacy as its exclusive commercial distribution partner for FORZINITY in the United States. Through this partnership, AnovoRx will play a key role in helping patients, caregivers, and healthcare providers navigate the insurance coverage and access process.

This includes: co-pay assistance for eligible commercially insured patients; patient assistance programs for uninsured or underinsured individuals; support for at-home subcutaneous injection training; and dedicated case management through AnovoRx to provide ongoing communication with patients, caregivers, and healthcare providers.

According to Stealth, patients currently receiving elamipretide through its Expanded Access Program who meet the weight requirement of 30 kg will be contacted directly by their healthcare providers and AnovoRx case managers to facilitate a seamless transition to commercial therapy once FORZINITY becomes available.

Stealth anticipates that the commercial product will be available through AnovoRx by December this year, pending final distribution readiness and payer coverage activation.