Last reviewed 2026-04-22 · How we verify

DHEA and Acolbifene

EndoCeutics Inc. · Phase 3 active Small molecule

DHEA and Acolbifene is a Selective estrogen receptor modulator (SERM) combination Small molecule drug developed by EndoCeutics Inc.. It is currently in Phase 3 development for Moderate to severe vasomotor symptoms associated with menopause, Vaginal atrophy and genitourinary syndrome of menopause. Also known as: Prasterone; dehydroepiandrosterone; EM-652.HCl.

DHEA and acolbifene work together as a selective estrogen receptor modulator (SERM) combination to provide estrogen-like benefits in bone and vaginal tissue while minimizing systemic estrogen exposure. Used for Moderate to severe vasomotor symptoms associated with menopause, Vaginal atrophy and genitourinary syndrome of menopause.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	DHEA and Acolbifene
Also known as	Prasterone; dehydroepiandrosterone; EM-652.HCl
Sponsor	EndoCeutics Inc.
Drug class	Selective estrogen receptor modulator (SERM) combination
Target	Estrogen receptor alpha and beta
Modality	Small molecule
Therapeutic area	Women's Health / Endocrinology
Phase	Phase 3

Mechanism of action

DHEA (dehydroepiandrosterone) is a prohormone that can be converted to estrogen and testosterone in peripheral tissues. Acolbifene is a selective estrogen receptor modulator that preferentially activates estrogen receptors in bone and vaginal tissue while avoiding activation in breast and endometrial tissue. Together, they aim to address menopausal symptoms and vaginal atrophy with a favorable safety profile.

Approved indications

Moderate to severe vasomotor symptoms associated with menopause
Vaginal atrophy and genitourinary syndrome of menopause

Common side effects

Hot flashes
Vaginal bleeding or spotting
Headache
Breast tenderness

Key clinical trials

Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

DHEA and Acolbifene CI brief — competitive landscape report
DHEA and Acolbifene updates RSS · CI watch RSS
EndoCeutics Inc. portfolio CI

Frequently asked questions about DHEA and Acolbifene

What is DHEA and Acolbifene?

DHEA and Acolbifene is a Selective estrogen receptor modulator (SERM) combination drug developed by EndoCeutics Inc., indicated for Moderate to severe vasomotor symptoms associated with menopause, Vaginal atrophy and genitourinary syndrome of menopause.

How does DHEA and Acolbifene work?

What is DHEA and Acolbifene used for?

DHEA and Acolbifene is indicated for Moderate to severe vasomotor symptoms associated with menopause, Vaginal atrophy and genitourinary syndrome of menopause.

Who makes DHEA and Acolbifene?

DHEA and Acolbifene is developed by EndoCeutics Inc. (see full EndoCeutics Inc. pipeline at /company/endoceutics-inc).

Is DHEA and Acolbifene also known as anything else?

DHEA and Acolbifene is also known as Prasterone; dehydroepiandrosterone; EM-652.HCl.

What drug class is DHEA and Acolbifene in?

DHEA and Acolbifene belongs to the Selective estrogen receptor modulator (SERM) combination class. See all Selective estrogen receptor modulator (SERM) combination drugs at /class/selective-estrogen-receptor-modulator-serm-combination.

What development phase is DHEA and Acolbifene in?

DHEA and Acolbifene is in Phase 3.

What are the side effects of DHEA and Acolbifene?

Common side effects of DHEA and Acolbifene include Hot flashes, Vaginal bleeding or spotting, Headache, Breast tenderness.

What does DHEA and Acolbifene target?

DHEA and Acolbifene targets Estrogen receptor alpha and beta and is a Selective estrogen receptor modulator (SERM) combination.

Drug class: All Selective estrogen receptor modulator (SERM) combination drugs
Target: All drugs targeting Estrogen receptor alpha and beta
Manufacturer: EndoCeutics Inc. — full pipeline
Therapeutic area: All drugs in Women's Health / Endocrinology
Indication: Drugs for Moderate to severe vasomotor symptoms associated with menopause
Indication: Drugs for Vaginal atrophy and genitourinary syndrome of menopause
Also known as: Prasterone; dehydroepiandrosterone; EM-652.HCl

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing