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, menopause, 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 Underway

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

Partner:

Investigational self-administered intravaginal contraceptive drug/device 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

Potential first-in-category for treatment of Female Sexual Arousal Disorder (FSAD) and/or female sexual interest/arousal disorder (FSAID)

Investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical administration to treat FSAD/FSAID. FSAD is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal during sexual activity. FSAID is defined in the DSM-5 as a lack of or significantly reduced sexual interest/arousal.  There are currently no FDA-approved treatments for FSAD or FSAID.  Learn More.

DARE-HRT1^‡

Menopausal Hormone Therapy

IND and Phase 3 Study Preparation

Potental first-in-category vaginal combination hormone delivery for treatment of vasomotor and vaginal symptoms due to menopause

Self-administered intravaginal ring (IVR) designed to release bio-identical estradiol and bio-identical progesterone over 28 days. There are currently no FDA-approved options with both hormones in one monthly IVR. Potential to be the first convenient monthly format product with both hormones.  Learn More.

DARE-VVA1^‡

Vulvar and Vaginal Atrophy (VVA)

Phase 2 Study Preparation

Potential first-in-category hormone-free intravaginal treatment for VVA

Proprietary formulation of tamoxifen for vaginal administration. There are currently no FDA-approved vaginal hormone-free treatments for VVA. Learn More.

DARE-PDM1^

Primary Dysmenorrhea

Phase 1 Study Completed

Potential First-in-Category Treatment for Primary Dysmenorrhea

Proprietary hydrogel formulation of diclofenac for vaginal administration. Alternative to oral nonsteroidal anti-inflammatory drugs and hormonal contraceptives, which often can produce undesirable side effects. There are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea. Learn more…

DARE 204/214^

6 & 12 Month Injectable Contraception

Phase 1 Study Preparation

Potential 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. There are currently no FDA-approved injectible contraceptives indicated for 6 & 12 months of protection.

DARE-FRT1/PTB1^

Pregnancy Maintenance

Phase 1 Study Preparation

First-in-category Sustained Release Progesterone for Pregnancy Maintenance

Progesterone delivery for pregnancy maintenance including the prevention of preterm birth (DARE-PTB1) and for luteal phase support as part of an IVF regimen (DARE-FRT1). IVR designed to release bio-identical progesterone for up to 14 days as an alternative to daily IM injections or vaginal gel. There are currently no FDA-approved products marketed in the U.S. that do not require daily dosing of progesterone.

DARE-LARC1^

Long-Acting, Reversible Personal Contraceptive System

Pre-clinical

Potental first-in-category, user controlled, long-acting, Reversible contraceptive

Levonorgestrel-releasing, long-acting contraceptive implant that a woman can turn on and off herself, according to her own needs. Grant of up to $48.95 M to advance technology through non-clinical proof of principle to enable IND submission. There are currently no FDA-approved contraceptive implants available that allow one to remotely pause and resume dosing.  Learn More.

DARE-LBT

Hydrogel Formulation for Delivery of Live Biotherapeutics to Support Vaginal Health

Pre-clinical

Hydrogel formulation for the delivery of live biotherapeutics to support vaginal health

Reconstitutable vaginal thermosetting gel formulation to serve as a delivery vehicle to allow administration of live biotherapeutics at the point of care in a wide range of settings to support vaginal health.  There are currently no FDA-approved live biotherapeutics for vaginal health.

DARE-GML

Novel Antimicrobial Glycerol Monolaurate

Pre-clinical

Potential First-in-category Multi-Target Antimicrobial (GML)

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

DARE-RH1

Male or Female Contraceptive Target

Pre-clinical

Potential First-in-category Male or Female Contraceptive Target

Investigational reversible, non-hormonal contraceptive solution with application for women and men. There are currently no FDA-approved contraceptives available that target sperm hypermotility required for implantation.

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

‡DARE-HRT1, DARE-VVA1, and DARE-PDM1 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

Contraception (2024) Advance online publication

Author(s)

Davis, et al.

Date

2/9/2024

Related Daré Candidate or Platform

Ovaprene®

Publication/Event

Contraception, Vol. 132, April 2024

Author(s)

Mauck, et al.

Date

1/15/2024

Related Daré Candidate or Platform

Ovaprene®

Publication/Event

Menopause: The Journal of The North American Menopause Society, Vol. 30, No. 9, 2023

Author(s)

Thurman, et al.

Date

8/9/2023

Related Daré Candidate or Platform

DARE-HRT1

Publication/Event

Menopause: The Journal of The North American Menopause Society, Vol. 30, No. 8, p 817-823, August 2023

Author(s)

Thurman, et al.

Date

6/21/2023

Related Daré Candidate or Platform

DARE-HRT1

Publication/Event

Climacteric (2023)

Author(s)

Hull, et al.

Date

4/13/2023

Related Daré Candidate or Platform

DARE-HRT1

Publication/Event

Menopause: The Journal of The North American Menopause Society, Vol. 30, No. 4, p 427-436, April 2023

Author(s)

Hull, et al.

Date

1/24/2023

Related Daré Candidate or Platform

DARE-HRT1

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

The Journal of Sexual Medicine. 2023 Feb 27; 20(3):277-286

Author(s)

Symonds, et al.

Date

2/27/2023

Related Daré Candidate or Platform

Sildenafil Cream, 3.6%

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

Climacteric (2023)

Author(s)

Thurman, et al.

Date

6/08/2023

Related Daré Candidate or Platform

DARE-VVA1

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.