gamma-Hydroxybutyric acid

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
Low Sodium Oxybate as a Treatment for Nocturnal Cluster Headache	2025/04/30	NCT06950281	Phase 2	Not yet recruiting	Leiden University Medical Center
Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy	2024/05/20	NCT06421532	Phase 2	Not yet recruiting	Leiden University Medical Center
A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy	2023/05/22	NCT05869773	Phase 4	Completed	Jazz Pharmaceuticals
Low Sodium Oxybate in Patients With Idiopathic Hypersomnia	2023/05/01	NCT05837091	Phase 4	Recruiting	Mayo Clinic
Sodium Oxybate Versus Midazolam for Comfort Sedation	2021/10/20	NCT05085873	Phase 4	Completed	Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy	2021/03/12	NCT04794491	Phase 4	Completed	Jazz Pharmaceuticals
Towards a Post-exposition Pharmacological Prophylaxis for Post-traumatic Stress Disorder	2020/08/11	NCT04508166	Not Applicable	Completed	Psychiatric University Hospital, Zurich
Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat	2020/03/26	NCT04322214	Phase 1	Completed	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.	2019/09/09	NCT04082806	Phase 2	Completed	Erich Seifritz
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension	2018/05/22	NCT03533114	Phase 3	Completed	Jazz Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
XYWAV	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	JAZZ PHARMACEUTICALS IRELAND LIMITED	02538237	Solution - Oral	0.096 G / ML	10/4/2023
XYWAV	JAZZ PHARMACEUTICALS IRELAND LIMITED	02538237	Solution - Oral	0.13 G / ML	10/4/2023
XYWAV	JAZZ PHARMACEUTICALS IRELAND LIMITED	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.

Related News

Jazz Pharmaceuticals Names Renee Gala as CEO in Strategic Leadership Transition

13 days ago

Jazz Pharmaceuticals' Board of Directors unanimously selected Renee Gala as President and CEO, effective August 11, 2025, succeeding co-founder Bruce Cozadd who will remain as Board Chairperson.

Jazz Pharmaceuticals Reports Strong Q1 2025 Performance with $898 Million in Revenue, Advances Pipeline with Zepzelca sNDA Submission

3 months ago

• Jazz Pharmaceuticals reported total revenues of $898 million in Q1 2025, with Xywav and Epidiolex showing strong year-over-year growth of 9% and 10% respectively. • The company submitted a supplemental New Drug Application for Zepzelca in combination with atezolizumab as maintenance therapy for first-line extensive-stage small cell lung cancer, based on promising Phase 3 trial results. • Jazz completed the acquisition of Chimerix, adding dordaviprone to its late-stage pipeline for H3 K27M-mutant diffuse glioma, with an FDA PDUFA target date of August 18, 2025.

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