OurPipeline*

Advancing Products Women Want

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 initiation planned 4Q 2019

Potential First-line Option for Bacterial Vaginosis

DARE-BV1 (bio-adhesive gel, clindamycin) is a potential front-line option for the treatment of bacterial vaginosis (BV). Thermosetting, prolonged-release antibiotic formulation aims to help treat once and done. Learn More.

Ovaprene®

Hormone-Free, Monthly Contraception

Pre-pivotal PCT* trial top line data expected 4Q 2019

First-in-category Hormone-Free, Monthly Contraception

Ovaprene (barrier IVR, ferrous gluconate) is designed to provide multiple weeks of contraceptive protection. Hormone-free, self-administered.  Learn More.

Sildenafil Cream, 3.6%

Female Sexual Arousal Disorder

Phase 2b "at home study" initiation planned 4Q 2019

First-in-category for Treatment of Female Sexual Arousal Disorder

Sildenafil Cream, 3.6% (Topical Cream, Sildenafil) is a topical formulation specially made for women with female sexual arousal disorder, targeted to reach where it matters most.  Learn More.

DARE-HRT1^‡

Hormone Replacement Therapy

Phase 1 initiation planned 4Q 2019

First-in-category Sustained-Release Hormone Replacement Therapy

DARE-HRT1 (IVR, combination bio-identical estradiol + bio-identical progesterone) for hormone replacement therapy.

DARE-VVA1^

Vulvar and Vaginal Atrophy
(HR+ Breast Cancer Population)

Phase 1 initiation planned 2020

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

DARE-VVA1 (vaginal insert, tamoxifen) is a proprietary formulation of tamoxifen for vaginal administration. Potential to be the first product specifically approved for the treatment of vulvar and vaginal atrophy (VVA) in patients with hormone-receptor positive (HR+) breast cancer.

DARE-FRT1^

Pregnancy Maintenance (PTB & ART)

Phase 1 initiation planned 2020

First-in-category Sustained Release Progesterone for Pregnancy Maintenance

DARE-FRT1 (IVR, bio-identical progesterone) for the prevention of preterm birth and for fertility support as part of an IVF treatment plan.

ORB 204/214^

6 & 12 Month Injectable Contraception

Pre-clinical

First-in-category 6 & 12 Month Injectable Contraception

A potential new injectable contraceptive that is designed to provide discreet, noninvasive, longer-acting reversible protection.

DARE-RH1

Non-Hormonal Male and Female Contraceptive Target

Pre-clinical

First-in-category Male or Female Contraceptive Target

A novel approach to male and female contraception.

Microchips

User-Controlled, Long-Acting Reversible Contraception

Pre-clinical

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

A novel integrated drug/device technological approach to long-acting, reversible contraception. Learn More.

^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.