Last reviewed 2026-04-19 · How we verify

PREGNENOLONE SUCCINATE

Phase 3 active Small molecule

PREGNENOLONE SUCCINATE is a pregnenolone drug. It is currently in Phase 3 development.

Pregnenolone succinate works by binding to sex hormone-binding globulin, potentially altering the levels of sex hormones in the body.

Pregnenolone succinate is a small molecule drug in the pregnenolone class, targeting sex hormone-binding globulin. Its mechanism of action and clinical uses are not well-documented, and it is unclear if it is FDA-approved or commercially available. As a result, there is limited information available on its safety profile, pharmacokinetics, or generic status. Further research is needed to fully understand this compound. Its development history is also unclear.

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	PREGNENOLONE SUCCINATE
Drug class	pregnenolone
Target	Corticosteroid-binding globulin, Glucose-6-phosphate 1-dehydrogenase, Sex hormone-binding globulin
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Mechanism of action

Imagine sex hormone-binding globulin as a protein that carries sex hormones like estrogen and testosterone. Pregnenolone succinate binds to this protein, which can affect how much of these hormones are available to the body. This can potentially impact various bodily functions and processes.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

PREGNENOLONE SUCCINATE CI brief — competitive landscape report
PREGNENOLONE SUCCINATE updates RSS · CI watch RSS

Frequently asked questions about PREGNENOLONE SUCCINATE

What is PREGNENOLONE SUCCINATE?

PREGNENOLONE SUCCINATE is a pregnenolone drug.

How does PREGNENOLONE SUCCINATE work?

Pregnenolone succinate works by binding to sex hormone-binding globulin, potentially altering the levels of sex hormones in the body.

What drug class is PREGNENOLONE SUCCINATE in?

PREGNENOLONE SUCCINATE belongs to the pregnenolone class. See all pregnenolone drugs at /class/pregnenolone.

What development phase is PREGNENOLONE SUCCINATE in?

PREGNENOLONE SUCCINATE is in Phase 3.

What does PREGNENOLONE SUCCINATE target?

PREGNENOLONE SUCCINATE targets Corticosteroid-binding globulin, Glucose-6-phosphate 1-dehydrogenase, Sex hormone-binding globulin and is a pregnenolone.

Drug class: All pregnenolone drugs
Target: All drugs targeting Corticosteroid-binding globulin, Glucose-6-phosphate 1-dehydrogenase, Sex hormone-binding globulin
Therapeutic area: All drugs in Other

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