Pregnenolone

Overview

A 21-carbon steroid, derived from cholesterol and found in steroid hormone-producing tissues. Pregnenolone is the precursor to gonadal steroid hormones and the adrenal corticosteroids.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A New Intervention to Improve Function in Veterans With Anxiety and Depression	2024/01/03	NCT06188923	Phase 2	Not yet recruiting	VA Office of Research and Development
Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial	2023/07/07	NCT05935761	Phase 2	Not yet recruiting	VA Office of Research and Development
Pregnenolone for the Treatment of Alcohol Use Disorder	2023/03/23	NCT05781009	Phase 2	Recruiting	Yale University
Novel Intervention for Chronic Complex TBI in OEF/OIF/OND Veterans	2023/01/05	NCT05671692	Phase 2	Not yet recruiting	Christine Marx, MD
Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV	2022/10/07	NCT05570812	Phase 2	Recruiting	Massachusetts General Hospital
Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects	2022/09/26	NCT05554926	Phase 1	Completed	Aelis Farma
Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD)	2022/04/12	NCT05322941	Phase 2	Completed	Aelis Farma
Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder	2020/07/09	NCT04464148	Phase 1	Withdrawn	University of Texas Southwestern Medical Center
The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders	2019/05/16	NCT03953612	Early Phase 1	Completed	Yale University
Neurosteroids for PTSD in Veterans	2019/01/10	NCT03799562	Phase 2	Recruiting	VA Office of Research and Development

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Aelis Farma's AEF0117 Fails Phase 2B Trial for Cannabis Use Disorder

10 months ago

• Aelis Farma's AEF0117 did not meet its primary endpoint of reducing cannabis use to one day or less per week in patients with moderate to severe cannabis use disorder (CUD). • The Phase 2B trial also failed to meet secondary endpoints, including complete cessation of marijuana use or reduction to two days or less per week. • Indivior, which had an option to license AEF0117, announced it does not currently expect to exercise this option due to the lack of separation from placebo in the trial. • AEF0117 was well-tolerated, with adverse events similar across treatment groups, including placebo, indicating no significant safety concerns.

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