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

Approved

XACIATO™

Bacterial Vaginosis
Collaborator: Organon

FDA Approval of XACIATO™ (clindamycin phosphate) vaginal gel, 2% on December 7, 2021

XACIATO™ (clindamycin phosphate) vaginal gel, 2%

Ovaprene®

Hormone-Free, Monthly Contraception
Collaborators: Bayer & NIH

Pivotal Phase 3 Study Recruitment Initiation Targeted for Mid-2023

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 Completed Screening 4Q 2022

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 1/2 Study Completed 4Q 2022

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 1/2 Study Completed 4Q 2022

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. Learn More.

DARE-FRT1/PTB1^

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.

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-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.

DARE-GML

Novel Antimicrobial Glycerol Monolaurate

Pre-clinical

First-in-category Multi-Target Antimicrobial

Glycerol monolaurate has the potential to deliver broad antimicrobial activity to treat a variety of bacterial, fungal, and viral vaginal infections.

DARE-LBT

Hydrogel Formulation for Delivery of Live Biotherapeutics to Support Vaginal Health

Pre-clinical

Novel hydrogel formulation for the delivery of live biotherapeutics to support vaginal health

Reconstitutable vaginal thermosetting gel formulation to ultimately serve as a delivery vehicle that allows administration of live biotherapeutics at the point of care in a wide range of settings to support vaginal health.

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.

‡DARE-HRT1 and DARE-VVA1 Phase 1 studies conducted in Australia by Daré subsidiary.

*This timeline reflects management’s estimates in the most recently filed corporate presentation and constitutes a forward-looking statement subject to qualifications described in the Terms of Service, 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 & Clinical Publications

Publication/Event

Author(s)

Name/Title

Date

Related Daré Candidate or Platform

Publication/Event

13th European Congress on Menopause and Andropause

Author(s)

Hull, et al.

Date

9/8/2021

Related Daré Candidate or Platform

DARE-HRT1

Publication/Event

9th Annual Partnership Opportunities in Drug Delivery Conference

Author(s)

Friend

Date

10/7/2019

Related Daré Candidate or Platform

DARE-HRT1, DARE-FRT1, DARE-PTB1

Publication/Event

2019 Controlled Release Society Annual Meeting & Exposition

Author(s)

Kiang and Friend

Date

7/22/2019

Related Daré Candidate or Platform

DARE-HRT1

Publication/Event

2019 Controlled Release Society Annual Meeting & Exposition

Author(s)

Kiang and Friend

Date

7/22/2019

Related Daré Candidate or Platform

DARE-HRT1

Publication/Event

Journal of Pharmaceutical Sciences 108 (2019) 2677-2684

Author(s)

Weiss, et al.

Date

4/5/2019

Related Daré Candidate or Platform

DARE-HRT1

Publication/Event

Drug Delivery and Translational Research (2019) 9:1008–1016

Author(s)

Weiss, et al.

Date

5/7/2019

Related Daré Candidate or Platform

DARE-PTB1

Publication/Event

International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting 2020

Author(s)

Goldstein, et al.

Date

3/9/2020

Related Daré Candidate or Platform

Sildenafil Cream, 3.6%

Publication/Event

International Journal of Pharmaceutics 570 (2019) 118691

Author(s)

Chollet, et al.

Date

9/10/2019

Related Daré Candidate or Platform

DARE-VVA1

Publication/Event

2021 Controlled Release Society Virtual Annual Meeting

Author(s)

Mauck, et al.

Date

7/27/2021

Related Daré Candidate or Platform

XACIATO™ (clindamycin phosphate) vaginal gel, 2%

Publication/Event

AIDS RESEARCH AND HUMAN RETROVIRUSES, Volume 36

Author(s)

Guthrie, et al.

Date

11/12/2020

Related Daré Candidate or Platform

XACIATO™ (clindamycin phosphate) vaginal gel, 2%; vaginal hydrogel

Publication/Event

2019 Annual Meeting of Infectious Diseases Society for Obstetrics and Gynecology

Author(s)

Dupre, et al.

Date

8/8/2019

Related Daré Candidate or Platform

XACIATO™ (clindamycin phosphate) vaginal gel, 2%

This page is intended to provide scientific and clinical research information solely for informational purposes. The publications and presentations listed here do not represent all of the information available on the topics addressed or related to our development programs. Our first product was approved by the U.S. Food and Drug Administration (FDA) in December 2021. Learn more here. None of our investigational products or potential product candidates, including Ovaprene®, Sildenafil Cream 3.6%, DARE-HRT1, DARE-VVA1, DARE-FRT1, DARE-PTB1, DARE-LARC1, ADARE 204/214 and DARE-RH1, has been approved by the FDA or any other regulatory agency for use outside of a clinical trial.