MedPath

gamma-Hydroxybutyric acid

Generic Name
gamma-Hydroxybutyric acid
Brand Names
Xywav
Drug Type
Small Molecule
Chemical Formula
C4H8O3
CAS Number
591-81-1
Unique Ingredient Identifier
30IW36W5B2

Overview

Gamma hydroxybutyric acid, commonly abbreviated GHB, is a therapeutic drug which is illegal in multiple countries. It is currently regulated in the US and sold by Jazz Pharmaceuticals under the name Xyrem. However, it is important to note that GHB is a designated Orphan drug (in 1985). Today Xyrem is a Schedule III drug; however GHB remains a Schedule I drug and the illicit use of Xyrem falls under penalties of Schedule I. GHB is a naturally occurring substance found in the central nervous system, wine, beef, small citrus fruits and almost all other living creatures in small amounts. It is used illegally under the street names Juice, Liquid Ecstasy or simply G, either as an intoxicant, or as a date rape drug. Xyrem is a central nervous system depressant that reduces excessive daytime sleepiness and cataplexy in patients with narcolepsy.

Indication

Used as a general anesthetic, to treat conditions such as insomnia, clinical depression, narcolepsy, and alcoholism, and to improve athletic performance.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/30
Phase 2
Not yet recruiting
Leiden University Medical Center
2024/05/20
Phase 2
Not yet recruiting
Leiden University Medical Center
2023/05/22
Phase 4
Completed
2023/05/01
Phase 4
Recruiting
2021/10/20
Phase 4
Completed
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
2021/03/12
Phase 4
Completed
2020/08/11
Not Applicable
Completed
Psychiatric University Hospital, Zurich
2020/03/26
Phase 1
Completed
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
2019/09/09
Phase 2
Completed
Erich Seifritz
2018/05/22
Phase 3
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Jazz Pharmaceuticals, Inc.
68727-150
ORAL
0.5 g in 1 mL
3/10/2022

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.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
XYWAV
02538237
Solution - Oral
0.096 G / ML
10/4/2023
XYWAV
02538237
Solution - Oral
0.13 G / ML
10/4/2023
XYWAV
02538237
Solution - Oral
0.234 G / ML
10/4/2023

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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