The goal of this study is to better understand the relationship between peripheral and central nervous system measurements of the gamma-aminobutyric acid (GABA) system in otherwise healthy individuals. the main questions it aims to answer are:
1. Does GABA cross the blood-brain barrier?
2. Can peripheral measurements of the GABAergic system be used to study GABA in the brain?
Participants will receive oral GABA and Placebo and undergo blood draws, MRI scans and transcranial magnetic stimulation sessions.

Start Date05 May 2025

Sponsor / Collaborator

University of Sherbrooke

IRCT20240408061452N1

/ CompletedPhase 2/3IIT

Effect of GABA-producing probiotic bacteria on decreasing seizures in children with refractory epilepsy

Start Date20 Apr 2024

Sponsor / Collaborator

Mashhad University of Medical Sciences

ChiCTR2400082462

/ SuspendedEarly Phase 1IIT

A randomized, double-blind, placebo-controlled study of foodborne GABA for mild to moderate anxiety disorders

Start Date05 Apr 2024

Sponsor / Collaborator-

100 Clinical Results associated with Gamma-Aminobutyric Acid

100 Translational Medicine associated with Gamma-Aminobutyric Acid

100 Patents (Medical) associated with Gamma-Aminobutyric Acid

59,675

Literatures (Medical) associated with Gamma-Aminobutyric Acid

31 Dec 2025·Gynecological Endocrinology

Dysregulated serum levels of kisspeptin, NKB, GABA in women with polycystic ovary syndrome and their association with hormonal profiles

Article

Author: Fang, Xiao-hong ; Zhang, Qin ; Xiao, Lu ; Yang, Liu-qing ; Zhu, Ying ; Cheng, Ran

INTRODUCTIONThe clinical study aimed to evaluate the levels of serum kisspeptin, NKB, and GABA in Chinese patients with polycystic ovary syndrome (PCOS) and explore their association with hormonal profiles, as well as the relationship between these levels in PCOS patients and controls.METHODSFrom December 2022 to December 2023, medical records of 60 individuals diagnosed with PCOS and 32 healthy subjects were obtained. Serum kisspeptin, NKB and GABA levels were quantified using enzyme-linked immunosorbent assay (ELISA) kits. To assess the correlation, either Pearson's or Spearman's analytical method was employed between serum kisspeptin, NKB, and GABA levels and hormonal profiles.RESULTSThe results showed that serum kisspeptin and NKB levels were significantly lower in PCOS patients (p﹤.05), while GABA levels were elevated compared to those in the control group (p﹤.05). In PCOS patients, kisspeptin was notably positive-correlated with LH and LH/FSH (p﹤.05), but no significant correlation was found between NKB, GABA, and hormonal profiles. In PCOS, GABA levels had a strong positive correlation with NKB levels (r = 0.613, p = .000), but this was not observed in the control group. In control patients, kisspeptin levels were positively associated with NKB (r = 0.475, p = .011), strongly negatively correlated with GABA levels (r = -0.773, p = .000), but these were not observed in the PCOS group.CONCLUSIONThe study concluded that patients with PCOS have dysregulated levels of serum kisspeptin, NKB, and GABA and that they may have paradoxical effects under physiological and pathological situations.

01 Dec 2025·Functional & Integrative Genomics

Transforming tomatoes into GABA-rich functional foods through genome editing: A modern biotechnological approach

Review

Author: Balasubramanian, Rajagopal ; Sampathrajan, Vellaikumar ; Sakthivel, Kausalya ; Appachi, Sathiyamurthy V ; K K, Kumar ; Veerasamy, Ravichandran

Gamma-aminobutyric acid (GABA) functions as an inhibitory neurotransmitter which blocks the impulses between nerve cells in the brain. Due to the increasing awareness about the health promoting benefits associated with GABA, it is also artificially synthesized and consumed as a nutritional supplement by people in some regions of the world. Though among the fresh vegetables, tomato fruits do contain a comparatively higher amount of GABA (0.07 to 2.01 mg g^-1 FW), it needs to be further enhanced to fully impart its potential health benefits. Achieving this feat through classical breeding approaches is time and resource consuming, and is also associated with linkage drag. On the other hand, precise targeting of specific sites in the genome with less off- target effects is mediated by CRISPR/Cas9 genome editing tool and is widely used to overcome the barriers associated with traditional breeding approaches. Combining genome editing with speed breeding techniques can enable the rapid development of GABA-rich tomato cultivars, paving a way to unlock a new era of functional foods, where every bite contributes to cognitive well-being and holistic health. This review highlights the significance of GABA boosted functional foods and explores the potential of CRISPR/Cas9 technology for developing GABA enriched tomatoes.

01 Dec 2025·Molecular Biology Reports

GABA mitigates mitochondrial apoptosis induced by high temperature stress in the Pacific oyster (Crassostrea gigas)

Article

Author: Wang, Lingling ; Zhang, Xueshu ; Xing, Zhen ; Zhang, Ziyang ; Song, Linsheng ; Liu, Ranyang ; Li, Qingsong ; Gao, Lei

BACKGROUNDHigh temperature is a critical environmental factor leading to mass mortality in oyster aquaculture in China. Recent advancements highlight the physiological regulation function of γ-aminobutyric acid (GABA) in the adaptation of environmental stress.METHODS AND RESULTSThis study examined the physiological responses of the Pacific oyster (Crassostrea gigas) upon high temperature exposure, focusing on the histopathological changes in gill, the GABA concentration, the mRNA expression and activities of apoptosis-related genes. Following 24 h of exposure to seawater at 28 °C, notable histopathological changes, including cellular swelling and vacuolization, along with an increase in TUNEL-positive cells were observed in the oyster gill, compared to the control group maintained at 18 °C. Moreover, there was a significant increase in CgCaspase-3 transcripts, Caspase-3 and Caspase-9 activities in the gills, glutamate decarboxylase CgGAD transcripts in the haemocytes, and GABA concentrations in the haemolymph supernatant. Intervention with GABA markedly ameliorated these responses, including reducing the mRNA expression levels of CgBax, CgBak, CgCaspase-3, and CgCaspase-9, as well as the activities of Caspase-3/9. Furthermore, after the treatment with GABA_A and GABA_B receptor antagonists, the activities and expression levels of Caspase-3 and Caspase-9 significantly up-regulated under hightemperature stress. GABA treatment also significantly diminished the increased Caspase-3 activity by mitochondrial pathway apoptosis inducers.CONCLUSIONSHigh temperature induced mitochondrial pathway apoptosis via increased caspase activities. The transcripts of CgGAD in haemocytes and GABA concentration in hemolymph supernatant also increased after high-temperature stress. GABA countered these effects through the activation of GABA_A and GABA_B receptors, reducing both caspase activity and expression of apoptosis-related genes.

News (Medical) associated with Gamma-Aminobutyric Acid

29 Apr 2025

·www.prnewswire.com

Verb Biotics Unveils Breakthrough Clinical Results: GABA-Producing Probiotic LP815™ Shows Powerful Anxiety Relief

A clinical trial with People Science validates LP815's anxiety benefits and marks a major advance in gut-brain health. BOULDER, Colo., April 29, 2025 /PRNewswire/ -- Verb Biotics, in collaboration with leading decentralized clinical research organization People Science, announced promising results from a randomized, double-blind, placebo-controlled clinical trial demonstrating that daily supplementation with the GABA-producing probiotic strain Lactiplantibacillus plantarum, LP815™, significantly reduced anxiety levels in adults with mild to moderate anxiety (manuscript published in Beneficial Microbes). The six-week study evaluated the effects of LP815™ compared to placebo on anxiety, mood, sleep, and quality of life. The trial drew a diverse group of participants, 63% of whom were women. Participants who received 5 billion CFU per day experienced a clinically meaningful reduction in anxiety, with 68% improving by more than one category on the GAD-7 anxiety scale by week six, compared to just 26% in the placebo group. The study, conducted through People Science's innovative digital clinical trial platform Chloe, reflects a broader mission to make research more accessible. "By expanding access to research and delivering trustworthy data, we can empower individual wellness journeys—and when we do, everyone benefits," said Belinda Tan, Co-CEO and Co-founder of People Science. "This trial is a major step forward in understanding how GABA-producing probiotics can influence mood and mental well-being through the gut-brain axis," said Todd Beckman, CEO of Verb Biotics. "Partnering with People Science allowed us to deliver a high-quality, real-world clinical study and further validate the potential of LP815™ as a safe, effective solution for supporting mental well-being." GABA (gamma-aminobutyric acid) is the brain's primary inhibitory neurotransmitter, playing a critical role in regulating mood and sleep. By delivering functionally focused health solutions like LP815™, Verb Biotics is pioneering a new era of gut-brain health designed to meet the growing consumer demand for natural, science-backed mental wellness support. "We've long understood the vital role GABA plays within the central nervous system, but now we're seeing how targeted microbial interventions can drive measurable changes in mental health outcomes," added Noah Zimmerman, PhD, Chief Scientific Officer at Verb Biotics. "This study is a key demonstration of how gut-brain axis solutions can be thoughtfully designed and clinically proven to improve quality of life." The findings contribute to a growing body of evidence that gut microbiome interventions—particularly those leveraging the gut-brain axis—can unlock new frontiers in accessible mental wellness solutions. Building on these exciting results, Verb Biotics is preparing to launch a new clinical study focused specifically on how LP815™ may impact sleep quality, further expanding scientific understanding of this strain's benefits for overall mental well-being. About Verb Biotics Verb Biotics is a microbiome innovation company aiming to improve human and companion animal health. Verb's "biotic" ingredients deliver targeted mechanism of actions for functional health categories, such as gut-brain health. To learn more about Verb's microbiome ingredient solutions, please visit . About People Science Founded by the pioneers of decentralized clinical trials, People Science is dedicated to transforming clinical research by making it more accessible, efficient, and data-driven. To learn more about People Science's clinical research solutions, please visit SOURCE Verb Biotics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical Result

14 Feb 2025

·www.pharmaceutical-technology.com

Newleos secures $93.5m for neuropsychiatric treatments

The company’s clinical-stage pipeline candidates target a range of conditions such as generalised anxiety, social anxiety, cognitive impairment and substance use disorders. Credit: UnderhilStudio/Shutterstock. Newleos Therapeutics has closed an oversubscribed Series A financing round, raising $93.5m to revolutionise neuropsychiatric disorder treatments with new medicines. Goldman Sachs Alternatives spearheaded the funding round which also saw contributions from Longwood Fund, Novo Holdings, Arkin Bio Ventures and DCVC Bio. Newleos in-licensed its clinical-stage pipeline from Roche, which comprises several oral small molecules with new mechanisms targeting a range of conditions such as generalised anxiety, social anxiety, cognitive impairment and substance use disorders. The company made an upfront payment and will provide success-based milestones and royalties in exchange for global rights to the clinical-stage assets. Newleos founding CEO and Longwood Fund executive partner David Donabedian stated: “Anxiety and substance use disorders represent some of the most prevalent neuropsychiatric indications with high unmet need, representing more than 25% of mental illnesses in US adults and impacting 60 million individuals. “With a seasoned founding team that has extensive company creation and central nervous system drug development experience, Newleos will use this capital to conduct proof-of-concept clinical trials across our programmes.” The company’s leading clinical programme, NTX-1955, is a gamma-aminobutyric acid type A (GABAA)-γ1 selective positive allosteric modulator (PAM) designed to treat anxiety disorders with a unique mechanism of action that avoids the side effects of current treatments. This targeted approach could minimise anxiety while avoiding other brain networks that carry safety risks. NTX-1955 has already undergone a non-clinical package and Phase I trials, which included single and multiple ascending dose studies, drug-drug interactions and receptor occupancy studies. The therapy is safe, well-tolerated, brain-penetrant and selective to GABAA-γ1. Newleos is planning to further investigate the candidate in proof-of-concept clinical trials for generalised anxiety disorder. Newleos has several other clinical-stage assets: NTX-1472, NTX-2001 and NTX-1511, which target V1a, TAAR1, and GABAA-α5 receptors respectively.

Phase 1Phase 2

13 Dec 2024

·www.prnewswire.com

Diamyd Medical Aligns with FDA on Key Elements for an Accelerated Approval Process

STOCKHOLM, Dec. 13, 2024 /PRNewswire/ -- Diamyd Medical today announced a positive in-person Type C meeting with the U.S. Food and Drug Administration (FDA), where alignment was achieved on key components of the planned early readout and an accelerated approval pathway for the antigen-specific immunotherapy, Diamyd® (rhGAD65/alum). Additional details of the FDA interaction will be disclosed upon receipt of the final meeting minutes, expected in January 2025. "We are very pleased with the positive and constructive dialogue and the alignment achieved with the FDA on key elements of the accelerated readout procedure," says Ulf Hannelius, CEO of Diamyd Medical. "This represents a significant milestone as we advance toward making Diamyd® available to patients with Type 1 Diabetes needing disease-modifying treatments. Importantly, the accelerated approval pathway could allow Diamyd® to reach the market more than a year earlier, addressing the urgent need for innovative therapies." The early readout, planned for March 2026 for the ongoing Phase 3 DIAGNODE-3 trial, will include approximately 170 evaluable participants who have completed their 15-month assessment. As of today, 191 patients have been randomized in the trial. This analysis will provide efficacy data based on preservation of C-peptide levels, which the FDA, following a Type C meeting held in July 2024 with Diamyd Medical, recognizes as a surrogate endpoint reasonably likely to predict clinical benefit in Type 1 Diabetes, and can therefore be used to obtain Accelerated approval. About Diamyd Medical Diamyd Medical develops precision medicine therapies to prevent and treat Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd® is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production. Diamyd® has been granted Orphan Drug Designation in the U.S. as well as Breakthrough Designation and Fast Track Designation by the U.S. FDA for the treatment of Stage 3 Type 1 Diabetes. Diamyd® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase IIb trial, where Diamyd® was administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. Injections into a superficial lymphnode can be performed in minutes and are intended to optimize the treatment response. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd®. Diamyd Medical also develops the GABA-based investigational drug Remygen® as a component in the treatments of metabolic diseases. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB. Diamyd Medical's B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser. For further information, please contact: Ulf Hannelius, President and CEO Phone: +46 736 35 42 41 E-mail: [email protected] This information was brought to you by Cision The following files are available for download: SOURCE Diamyd Medical AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Fast TrackImmunotherapyOrphan DrugPhase 3

100 Deals associated with Gamma-Aminobutyric Acid

External Link

KEGG	Wiki	ATC	Drug Bank
D00058	Gamma-Aminobutyric Acid	N03AG03	DB02530

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Carbon Monoxide Poisoning	China	Tianjin Lisheng Pharmaceutical Co., Ltd.	01 Jan 1981
Intracranial Arteriosclerosis	China	Tianjin Lisheng Pharmaceutical Co., Ltd.	01 Jan 1981
Stroke	China	Tianjin Lisheng Pharmaceutical Co., Ltd.	01 Jan 1981
Brain Injury, Chronic	Japan	Alfresa Pharma Corp.	22 Nov 1961

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAI2023	Not Applicable	Glioblastoma	-	γ-aminobutyric acid (Female mice)	fmlpukrlwo(kmsnogfhvx) = bfccjceqtc bxnqpnnlar (xrzqpaiklo )	-	01 May 2023
				γ-aminobutyric acid (Male mice)	fmlpukrlwo(kmsnogfhvx) = oogbfqvsby bxnqpnnlar (xrzqpaiklo )
SFN2003	Not Applicable	-	-	GABA	wbxqpvcsua(momtptlmbr) = jpcjctidsg jcdenzonqq (cwwzjpgeln ) View more	-	11 Nov 2003
SFN2001	Not Applicable	-	-	Pentobarbital	pusfuendek(skuvkehtvo) = ssqgataiih ssqqccpyqa (rnmovwxiro )	-	13 Nov 2001
				GABA	pusfuendek(skuvkehtvo) = jxbdrlbspb ssqqccpyqa (rnmovwxiro )

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