Disseminated Coccidioidomycosis: Developing Drugs for Treatment Draft Guidance for Industry September 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/disseminated-coccidioidomycosis-developing-drugs-treatment?utm_medium=email&utm_source=govdelivery FDA Publishes Draft Guidance on Developing Drugs to Treat Disseminated Coccidioidomycosis (Valley Fever) The U.S. Food and Drug Administration (FDA) published a draft guidance, “Disseminated Coccidioidomycosis: Developing Drugs for Treatment” on Sept. 17. This guidance provides recommendations for sponsors developing treatments for disseminated coccidioidomycosis (Valley Fever), a serious fungal infection. Symptoms can include fever, cough, chest pain, joint pain, fatigue and night sweats. Disseminated coccidioidomycosis can affect multiple organ systems, e.g., the soft tissue, bone and joint, genital tract, peritoneal, and central nervous system (i.e., meningitis), and can require prolonged treatment. The guidance addresses clinical trial design, patient population selection, and efficacy endpoints. In particular, the guidance recommends primary efficacy endpoints based on clinical outcome assessments, such as patient-reported outcomes, to capture outcomes that are most meaningful to patients, can be improved with treatment, and are expected to be sufficiently sensitive to detect a treatment effect.