Patented, Transdermal Drug Delivery
Madera is developing a patented (US20250064830A1), transdermal drug delivery platform enabling drugs previously delivered only via injection to be effectively delivered topically. Our proprietary permeation compound acts as a chassis for existing FDA-approved drugs to attach to, enabling a variety of patient and provider benefits.
Revolutionizing Erectile Dysfunction (ED) Treatment
As of today, FDA-approved Alprostadil is the gold-standard for ED treatment. Unfortunately, Alprostadil is administered only via local injection or suppository. While safe and rapidly effective for virtually all patients, this method of delivery is largely rejected by patients, leaving enormous unmet demand in the ED treatment market.
Madera is currently working to deliver Alprostadil via its patented permeation innovation.
Addressing Unmet Demand
Existing ED oral medications, such as Sildenafil and Tadalafil, are ineffective in nearly 40% of patients. For the remaining 60% of patients, existing medications often result in significant and dangerous side effects, ranging from hearing and vision impairment, headaches, heart and blood pressure changes and more. Furthermore, patients with comorbidities such as cardiovascular disease, diabetes and more are unable to safely take these medications.
TOPICAL ALPROSTADIL
Local & Non-Systemic
Madera's topical application for Alprostadil is local and non-systemic. Alprostadil has been clinically shown to be effective for over 96% of patients.
Fast & Safe
Alprostadil has fast efficacy, in as little as 2 minutes, enabling patients flexibility of use without planning ahead. It has also shown to be free of side effects common with existing oral medications.
Comorbidity Safe
Alprostadil has been shown to be safe and effective for patients with comorbidities, such as cardiovascular disease and diabetes.
Madera is currently preparing its IND for submission in 2026 and will be filing its NDA with the FDA via the 505(b)(2) pathway in 2027.