What Cerulean Pharma does

Daré Bioscience, Inc. (the operating successor to Cerulean Pharma following a July 2017 business combination) is a clinical-stage women's health biotech that develops differentiated therapeutics for conditions historically underserved by the medical establishment, including contraception, menopause, HPV infection, vaginal health, and female sexual health. The company's core technology is built around proprietary vaginal drug delivery systems, including soft gel vaginal inserts (DARE-HPV, a fixed-dose lopinavir/ritonavir formulation for persistent high-risk HPV), topical sildenafil cream (DARE to PLAY), hormone-free knitted-polymer contraceptive devices (Ovaprene), hormone-free vaginal inserts for postmenopausal sexual pain (DARE-VVA1), and clinically studied vaginal probiotic capsules (Flora Sync LF5, containing the proprietary Limosilactobacillus fermentum LF5 strain). The company operates a dual-path commercialization model: pursuing traditional FDA approval for pipeline assets while leveraging Section 503B compounding to accelerate patient access for products like DARE to PLAY.

Revenue mechanics are in early stages. Flora Sync LF5, launched in June 2026 at $49 per box of 6 capsules, is sold direct-to-consumer through the DARE Health Hub e-commerce platform and represents the company's first product revenue. DARE to PLAY is available via pre-fulfillment prescription in all 50 states through pharmacy networks. The company is listed on NASDAQ as DARE, is headquartered in San Diego, California, and has 1-10 employees. Government grants — including a $2.0 million NIH NIAID SBIR award and an up to $10 million ARPA-H contract for the DARE-HPV program — provide non-dilutive capital alongside equity funding. The Ovaprene pivotal Phase 3 study is conducted under a CRADA with NICHD. The company has 0 FDA-approved products and a portfolio of sub-brands (DARE to PLAY, DARE to RESTORE, DARE to RECLAIM, DARE to SUPPORT, DARE to PLAN, DARE to FIGHT) addressing the full life-stage continuum of women's health needs.

Name

Cerulean Pharma

Legal name

Daré Bioscience, Inc.

Website

https://darebioscience.com

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

Daré Bioscience is a clinical-stage women's health biotech that develops and commercializes proprietary vaginal drug-delivery therapeutics—including vaginal probiotics, topical sildenafil, and clinical-stage candidates for HPV, contraception, and menopause—serving women across all life stages.

Ownership category

akta.pro rank

Product category

Women's Health Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Medicinal and Botanical Manufacturing (325411), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health) (HLAIAAAJ)

akta.pro secondary industries

Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE), Compounding Pharmacies (Sterile/Non-Sterile) (HLAFALAE)

Keywords

• Women's health therapeutics
• Vaginal drug delivery
• Clinical-stage biopharmaceuticals
• Hormone-free contraception
• HPV antiviral treatment

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Marketing or Sales, Supply Chain, Operations

Revenue model

1. Prescription Drug Products: Prescription-based pharmaceutical products including DARE to PLAY sildenafil cream, which is available for pre-fulfillment prescriptions in all 50 states. Revenue generated through pharmacy fulfillment networks.
2. Over-the-Counter Women's Health Products: Non-prescription consumer health products sold directly through the DARE Health Hub e-commerce platform, including Flora Sync LF5 vaginal probiotic capsules at $49 per box.
3. Government Grants and Contracts: Non-dilutive funding from NIH/NIAID grants ($2.0 million SBIR award for DARE-HPV) and ARPA-H contracts (up to $10 million for DARE-HPV Phase 2 study). Also includes NICHD CRADA for Ovaprene Phase 3 study.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Cerulean Pharma (now operating as Daré Bioscience, Inc.) develops and commercializes targeted therapeutics for women's health, including a compounded topical sildenafil cream (DARE to PLAY) and a vaginal probiotic capsule (Flora Sync LF5) sold through direct-to-consumer and pharmacy channels. The company is also advancing clinical-stage drug and drug/device candidates such as DARE-HPV (a soft gel vaginal insert for high-risk HPV) and Ovaprene (a hormone-free monthly contraceptive). It operates a dual-path model combining FDA approval pursuits with Section 503B compounding to accelerate patient access.

Product overview

Daré Bioscience (formerly Cerulean Pharma) is a purpose-driven health biotech company focused on women's health. The company operates a dual-path model—pursuing FDA approval pathways while leveraging Section 503B compounding—to accelerate access to differentiated therapies. The product portfolio spans consumer products (DARE to PLAY™ sildenafil cream, Flora Sync LF5™ vaginal probiotics) and an innovation pipeline including DARE-HPV (antiviral vaginal insert for HPV), Ovaprene® (hormone-free monthly contraceptive), DARE-VVA1 (vaginal insert for sexual pain), and multiple sub-brands under DARE to RESTORE™, DARE to RECLAIM™, DARE to SUPPORT™, DARE to PLAN™, and DARE to FIGHT™ covering contraception, menopause, vaginal health, pregnancy support, and infectious disease.

Differentiator

Problem solved

Functional benefit

Brands

• DARE to PLAY: First-of-its-kind topical female arousal cream with sildenafil for sexual health.
• DARE to RESTORE
• DARE to RECLAIM
• DARE to SUPPORT
• DARE to PLANTM
• DARE to FIGHTTM
• Flora Sync LF5
• DARE Health Hub

Products and services

• DARE to PLAY Sildenafil Cream First-of-its-kind topical female arousal cream containing 3.6% sildenafil, manufactured in a 503B outsourcing facility under pharmaceutical cGMP and available by prescription in all 50 U.S. states.
• Flora Sync LF5 Vaginal Probiotic Vaginal probiotic capsules containing Limosilactobacillus fermentum LF5, a strain isolated from the vaginal microbiome of healthy women, designed to restore microbiome balance and support vaginal comfort. Available without prescription at $49 per box (6 capsules).
• DARE-HPV Investigational proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert, in development as a non-surgical, localized, self-administered treatment for persistent high-risk HPV infection. Currently in Phase 2 clinical study.
• Ovaprene Investigational hormone-free monthly intravaginal contraceptive that combines a locally acting non-hormonal agent impeding sperm motility with a unique knitted polymer barrier that physically blocks sperm from entering the cervical canal. Currently in pivotal Phase 3 study.
• DARE-VVA1 Investigational hormone-free vaginal insert for sexual pain post-menopause or following breast cancer treatment.

Quantifiable outcome

• 96% of women achieved vaginal microbiome balance within 3 days; 90% maintained balance at 2 weeks (Flora Sync LF5 clinical trial, Frontiers in Microbiology 2024)
• +2 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)coreStrategic or Co-development Partner · 1 July 2021Cooperative Research and Development Agreement (CRADA) with NICHD/NIH for the pivotal Phase 3 study of Ovaprene. The agreement leverages NICHD's contraceptive clinical trial expertise while sharing costs of the Phase 3 pivotal study.
• ProbioticalcoreTechnology or IntegrationItalian probiotic company (founded 1985, with family legacy in lactic acid bacteria research dating back to 1920s) manufactures Flora Sync LF5 under current Good Manufacturing Practices (cGMP). Probiotical represents Daré's manufacturing partner for the vaginal probiotic product with expertise in evidence-based probiotic science, strain selection, and quality standards.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Agile Therapeutics: Clinical-stage women's health company focused on contraceptive products. Directly comparable as a small-cap public peer pursuing FDA approval in non-hormonal and hormonal contraception, overlapping with Daré's Ovaprene program.
• Myovant Sciences: Develops women's health and prostate cancer therapies, with approved products in heavy menstrual bleeding and endometriosis. Comparable as a focused women's health commercial-stage peer that grew via differentiated therapeutic approvals.
• TherapeuticsMD: Women's health-focused branded pharmaceutical company marketing prescription products in menopause, contraception, and vaginal health. Highly comparable business model to Daré's portfolio across DARE to RECLAIM and DARE to PLAN.
• Sebela Pharmaceuticals: Private/specialty pharmaceutical company with women's health portfolio including vaginal and reproductive health products. Comparable as a niche women's health commercial operator and a potential strategic acquirer for Daré assets.
• Veru Inc. Biopharmaceutical company focused on women's health (including sexual health) and oncology. Comparable to Daré's women's health focus and to DARE to PLAY's positioning in female sexual health.
• Mithra Pharmaceuticals: Belgian women's health company developing novel contraceptives and hormone therapy products. Comparable business model with differentiated women's health pipeline including non-hormonal contraception similar to Ovaprene.
• Evofem Biosciences: Women's health company commercializing hormone-free contraceptives and vaginal health products. Comparable in product type (vaginal pH regulator vs. Daré's vaginal probiotic and non-hormonal contraceptive) and target customer.

Broad incumbents

• Hologic: Large-cap women's health diagnostics and medical device company with significant HPV/cervical health franchise. Comparable at the category level (HPV, women's diagnostics) and represents a potential strategic acquirer of Daré's DARE-HPV asset.
• Organon & Co. Spun off from Merck as a global women's health incumbent with established franchises in contraception, fertility, and menopause. Provides a scaled comparator for Daré's pipeline ambitions across multiple women's health categories.
• Bayer (Women's Healthcare): Global incumbent in women's health with leading contraceptive and menopause franchises (Mirena, Yaz, etc.). Represents the dominant established competitor in the same prescription categories where Daré is launching.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/DareBioscience
• LinkedInlinkedin.com/company/dare-bioscience
• Instagraminstagram.com/darebioscience?utm_source=ig_web_button_share_sheet&igsh=ZDNlZDc0MzIxNw==

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds12 records

Investors9 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cerulean Pharma