OurPipeline*

Daring to be Different and Advancing Products Women Want

Daring to be Different and Advancing Products Women Want

We are committed to identifying, licensing or acquiring and developing candidates that expand options, improve outcomes and facilitate convenience for women. In addition to our lead products in development, our accelerator boasts a broad portfolio of diverse product candidates with first-in-category potential for women requiring or desiring new therapies in contraception, vaginal health, sexual health and fertility.

Pre-clinical

Phase 1

Phase 2

Phase 3

Regulatory Filing

DARE-BV1^

Bacterial Vaginosis

Phase 3 Topline Data Announced December 2020, NDA submitted 2Q2021, PDUFA target December 7, 2021

Potential First-line Option for Bacterial Vaginosis (Bioadhesive gel, clindamycin 2%)

Investigational thermosetting bioadhesive hydrogel single-administration vaginal treatment for bacterial vaginosis. In the DARE-BVFREE Phase 3 study, DARE-BV1 demonstrated the potential for improved clinical cure rates versus current branded FDA-approved products for the treatment of bacterial vaginosis. Learn More.

Ovaprene®

Hormone-Free, Monthly Contraception
Partners: Bayer & NIH

Pivotal Phase 3 Study Expected to Commence 2022

A novel, hormone-free monthly intravaginal contraceptive candidate (Self-administered intravaginal drug/device)

Partner:

Investigational hormone-free monthly intravaginal contraceptive designed to be an easy-to-use monthly option with effectiveness approaching hormonal methods; commercial partnership agreement with Bayer. There are currently no FDA-approved monthly hormone-free contraceptives. Learn More.

Sildenafil Cream, 3.6%

Female Sexual Arousal Disorder

Phase 2b Study Commenced 1Q2021

Potential first-in-category for treatment of Female Sexual Arousal Disorder (Topical cream, same active ingredient as Viagra®)

Investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical administration to treat FSAD. FSAD is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal during sexual activity, for which there are no FDA-approved treatments. Of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction in men. Learn More.

DARE-HRT1^‡

Hormone Therapy

Phase 1 Study Complete

First-in-category Sustained-Release Hormone Therapy

First-in-category combination hormone delivery for treatment of vasomotor and vaginal symptoms of menopause. Intravaginal ring (IVR) designed to release bio-identical estradiol and bio-identical progesterone over 28 days. Learn More.

DARE-VVA1^

Vulvar and Vaginal Atrophy

Phase 1 Preparation

First-in-category Treatment for VVA for ER/PR+ Breast Cancer Patients

First-in-category hormone-free vaginal treatment for vulvar and vaginal atrophy (VVA) in a hormone-receptor positive, breast cancer patient population. Proprietary formulation of tamoxifen for vaginal administration.

DARE-FRT1^

Pregnancy Maintenance

Phase 1 Preparation

First-in-category Sustained Release Progesterone for Pregnancy Maintenance

First-in-category progesterone delivery for pregnancy maintenance including the prevention of preterm birth and for luteal phase support as part of an IVF regimen. IVR designed to release bio-identical progesterone over 14 days.

DARE-LARC1^

Long-Acting, Reversible Personal Contraceptive System

Pre-clinical

First-in-category, User-Controlled, Long-Acting, Reversible Contraceptive (UC-LARC)

Levonorgestrel-releasing long-acting contraceptive implant that a woman can turn on and off herself, according to her own needs. Learn More.

ADARE 204/214^

6 & 12 Month Injectable Contraception

Pre-clinical

First-in-category 6 & 12 Month Injectable Contraception

Novel 6 & 12-month injectable formulations of etonogestrel being developed as a longer-acting, reversible method of contraception with a more predictable return to fertility.

DARE-RH1

Male or Female Contraceptive Target

Pre-clinical

First-in-category Male or Female Contraceptive Target

A potential new rapidly reversible, non-hormonal contraceptive solution with application for women and men.

^505(b)(2) regulatory pathway anticipated. *Ovaprene Post Coital Test (PCT) is a pre-pivotal clinical study.

‡HRT Phase 1 study to be conducted in Australia by Daré subsidiary.

*This timeline reflects management’s estimates as of August 30, 2019 and constitutes a forward-looking statement subject to qualifications under the Terms and Services of this website, including Section 13.4, Forward-Looking Statements; Disclaimer. Actual development timeline may be substantially longer, and Daré is under no obligation to update or review this estimate. “First-in-category” designation is a forward-looking statement based on management’s current expectations and currently available FDA-approved therapies.

Scientific

Publications*

Date

Details

Aug 8 – Aug 10, 2019

2019 Annual Meeting of the Infectious Diseases Society for Obstetrics and Gynecology

Location
Big Sky, Montana

Proof of Concept Study to Evaluate the Efficacy of a Novel Thermosetting Bioadhesive 2% Clindamycin Phosphate Vaginal Gel in the Treatment of Bacterial Vaginosis

April, 2019

Journal of Pharmaceutical Sciences

Pharmacokinetics and Tolerability of a Novel 17b-Estradiol and Progesterone Intravaginal Ring in Sheep

March, 2019

Clinical and Experimental Obstetrics & Gynecology

Weekly vaginal administration of tamoxifen for three months in postmenopausal women with vulvar and vaginal atrophy: a possible new treatment approach?

Nov 4 – Nov 7, 2018

November-December, 2009

The Journal of Reproductive Medicine®

A Pilot Safety and Tolerability Study of a Nonhormonal Vaginal Contraceptive Ring

*Disclaimer:  These publications have been prepared solely for illustration, educational and/or discussion purposes and are not intended to be relied upon for investment purposes. Under no circumstances should these publications or the information contained in them be used or considered as an offer, inducement, invitation, solicitation or recommendation to buy or sell any security or otherwise engage in any investment activity or as an expression of an opinion as to the present or future value or price of any security or financial instrument. Daré Bioscience does not guarantee the accuracy or completeness of any information appearing in third-party publications and is not liable for any delays, inaccuracies, errors in, or omissions from any such information, or for any actions taken in reliance on such information, or for any damages arising therefrom.