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Treatment pipeline

Sexual health treatment pipeline: what's coming

Newer FDA-authorized options and treatments being tested in registered clinical trials for erectile dysfunction, female sexual dysfunction, and vaginal symptoms of menopause. Every entry links to the FDA page or trial record it comes from.

Sources last checked: 2026-10-02

How to read this page:a trial being registered or underway does not mean the treatment works or will be approved. Many candidates never reach approval. A registry status is whatever the sponsor last reported, so an older “recruiting” listing may be out of date. Treatments in trials are things to watch, not things to wait for — options that are available today are covered in our guides.

Recently authorized by FDA

Eroxon (MED3000) gel

FDA-authorized

Erectile dysfunction

Authorized for marketing, June 2023

FDA authorized Futura Medical's Eroxon, a non-medicated hydro-alcoholic gel, for erectile dysfunction in adult men aged 22 and over. FDA described it as the first over-the-counter gel intended to treat erectile dysfunction. It works by a cooling-then-warming effect on nerve endings rather than by a drug ingredient.

Source: FDA Roundup, June 13, 2023 · checked 2026-10-02

Vyleesi (bremelanotide) injection

FDA-authorized

Hypoactive sexual desire disorder (premenopausal women)

Approved 2019

FDA approved Vyleesi in 2019 for acquired, generalized hypoactive sexual desire disorder in premenopausal women — low desire that causes marked distress and is not due to another condition, relationship problems or a medication. It activates melanocortin receptors; FDA notes the mechanism by which it improves desire is unknown. It is self-injected under the skin as needed.

Source: FDA, New Drug Therapy Approvals 2019 · checked 2026-10-02

In clinical trials

IncobotulinumtoxinA (Xeomin) injection added to tadalafil

Phase 2

Mild to moderate erectile dysfunction

Not yet recruiting (registry, updated Aug 2026)

A Northwestern University randomized crossover pilot study (estimated 30 participants) comparing intracavernosal Xeomin 100 units plus on-demand tadalafil 20 mg against placebo plus tadalafil. Primary outcomes are change in erectile function and erection hardness. This is an investigational use.

Source: ClinicalTrials.gov NCT07537855 · checked 2026-10-02

BZ371A topical gel after prostate surgery

Phase 2

Erectile dysfunction after radical prostatectomy

Registry status: recruiting (not updated since Oct 2024)

A Biozeus Biopharmaceutical trial (estimated 72 participants) testing a topically applied gel, BZ371A, after radical prostatectomy — alone and combined with daily tadalafil 5 mg — against placebo. The primary outcome is change in assisted erectile function.

Source: ClinicalTrials.gov NCT05558007 · checked 2026-10-02

BZ371A topical gel for arousal

Phase 2

Female sexual arousal disorder

Registry status: recruiting (not updated since Oct 2024)

A Biozeus Biopharmaceutical crossover study (estimated 30 participants) of BZ371A gel at three doses, each used daily for two weeks and compared with placebo, in women with sexual arousal disorder. The primary outcome is improvement in arousal.

Source: ClinicalTrials.gov NCT06116045 · checked 2026-10-02

Estetrol (E4) oral tablet

Phase 2

Female sexual arousal disorder (postmenopausal women)

Completed March 2025; results posted on the registry

A randomized, double-blind, placebo-controlled proof-of-concept trial by Estetra in 82 postmenopausal women with sexual arousal disorder, testing estetrol 20 mg once daily for 12 weeks. Outcomes include distress about arousal difficulties and an arousal-sensation questionnaire score. This is an investigational use.

Source: ClinicalTrials.gov NCT06308614 · checked 2026-10-02

AZU-101 (lasofoxifene) vaginal dose

Phase 2

Vulvovaginal atrophy / genitourinary syndrome of menopause

Registry status: recruiting (updated May 2026)

An Azure Biotech placebo-controlled proof-of-concept study (estimated 90 postmenopausal women) of a daily 1-microgram vaginal dose of lasofoxifene for 14 days. The primary goals are safety and how much of the drug reaches the bloodstream; effect on the vaginal lining is a secondary outcome.

Source: ClinicalTrials.gov NCT06197568 · checked 2026-10-02

We list a treatment only after checking it against an fda.gov page or its ClinicalTrials.gov record. We do not report trial results here unless we have read and cited them.

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