Initial Product Development, Proof of Concept and Animal Efficacy Study completed.
COMPLETED (2018-2022)
Patent awarded in August 2024, for discovery related to enhanced skin permeation of the active drug, Alprostadil. Additional claims will be filed.
(US PATENT AWARDED 2024)
Finalize product formulation, and related Chemistry, Manufacturing and Control (CMC), and Clinical Bridging. Complete Initial Drug Application (IND)
(ESTIMATED 14 MONTHS)
The safety and efficacy of the ingredients is well established for decades. The active ingredient is US FDA approved for injection.
(AFTER FDA FILING)
Work with Key Opinion Leaders to conduct human efficacy studies and CME presentations to Urologists to create awareness.
Obtain US FDA approval under the 505(b)(2) accelerated application process for novel topical delivery of existing injected drug product
(ESTIMATED 24-36 MONTHS)
Build doctor and patient awareness, drive demand and sell into Urology and Primary Care Physician channels.
Months 1 - 14
File With FDA
FDA Filing
submission
preparation
Months 15 - 24
Clinical Studies
36 person toxicity
and 120 person
efficacy studies
Months 15 - 36
Post Clinical
Operational, Marketing
and post-filing costs
Months 1 - 36
TOTAL FUNDING TO FDA APPROVAL
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