Effects of GABA with Butyrate, GABA/Butyrate-producing Synbiotics on Pain Relief in Fibromyalgia: A Phase II, Multi-Center, Double-Blinded, Randomized-Controlled Trial

Start Date02 Jan 2026

Sponsor / Collaborator

The Chinese University of Hong Kong

ChiCTR2500107572

/ Not yet recruitingNot ApplicableIIT

Research on the Mechanism of Action of Accelerated iTBS (aiTBS) in Regulating Glu/GABAergic Neural E/I Balance on Anhedonic Depression

Start Date15 Aug 2025

Sponsor / Collaborator-

NCT06464172

/ Not yet recruitingNot Applicable

The GABAergic System: Study of the Association Between Serum Measurements and Those Obtained Through Neuroimaging in Healthy Human Adults

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

100 Clinical Results associated with Gamma-Aminobutyric Acid

100 Translational Medicine associated with Gamma-Aminobutyric Acid

100 Patents (Medical) associated with Gamma-Aminobutyric Acid

46,852

Literatures (Medical) associated with Gamma-Aminobutyric Acid

01 Feb 2026·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Design, synthesis, and computational evaluation of ester prodrugs of isoguvacine as potential antiseizure medications

Article

Author: Maharani, Rani ; Sarian, Murni Nazira ; Feroz, Shevin Rizal ; Bakar, Khairul Azreena ; Ng, Yan Hong ; Supratman, Unang ; Latip, Jalifah ; Lam, Su Datt ; Muhajir, Muhamad Imam

Epilepsy, a neurological disorder affecting millions worldwide, has driven the development of various antiseizure medications (ASMs). Isoguvacine (IGV), a potent and selective agonist of the GABA_A receptor (GABA_AR), has shown potential in the treatment of epilepsy and other neurological disorders. However, its low blood-brain barrier permeability impairs its ability to act effectively within the central nervous system. To address this limitation, two novel ester derivatives of IGV, E7 and E14, were synthesized via Steglich esterification and evaluated through an integrated computational framework comprising density functional theory (DFT) calculations, molecular docking, molecular dynamics (MD) simulations, and in silico ADMET predictions. DFT analysis revealed that esterification significantly modified the electronic properties of IGV, with E14 exhibiting the highest polarizability (225.895 Å³) and smallest energy gap (-0.155 eV), indicative of enhanced reactivity. Molecular docking demonstrated that GABA (-8.46 kcal/mol) and IGV (-8.35 kcal/mol) exhibit similar binding affinity and complex stability with GABA_AR, supporting the reliability of our computational approach. MD simulations further confirmed the stability of these complexes, where lower RMSD, RMSF, and Rg values indicated that binding of GABA and IGV did not induce significant conformational changes in the overall receptor structure. Moreover, the derivatives were projected to exhibit optimal intestinal absorption (>90%), oral bioavailability, as well as favorable safety profiles with minimal interaction risks and non-carcinogenic properties. Collectively, these in silico findings highlight the potential of ester prodrug design to overcome the central pharmacokinetic limitations of IGV, with E14 emerging as the most promising ASM candidate for further experimental development in epilepsy therapy. Beyond identifying therapeutic advantages of E14, this study also underscores the broader value of integrated computational approaches as powerful and predictive tools in early-stage drug discovery for neurological disorders.

01 Jan 2026·BIORESOURCE TECHNOLOGY

pH-adaptive evolution of glutamate decarboxylase enables gamma-aminobutyric acid biosynthesis without pH control

Article

Author: Cheng, Zhongyi ; Liu, Zhongmei ; Han, Laichuang ; Qiao, Jun ; Zhou, Zhemin ; Luo, Jie ; Song, Chenshuo

The strict pH-dependent catalytic activity of glutamate decarboxylase (GAD) necessitates substantial acid consumption during γ-aminobutyric acid (GABA) biosynthesis, increasing costs and environmental impact. To overcome this limitation, we engineered glutamate decarboxylase from Escherichia coli (EcGadB) for enhanced activity at neutral pH. Using constant pH molecular dynamics (CpHMD) simulations, we targeted the pH-sensitive γ-carboxyl-binding loop (γ-CBL). Through three rounds of Adaptive Iterative Evolution (AIE) guided by a GABA biosensor, mutant M3 (Y51L/A56P/D68N/D69T) was obtained, which exhibited a 43.5-fold enhancement in catalytic efficiency (k_cat/K_m) at pH 7.5. Gaussian-accelerated MD simulations indicated that M3 stabilizes catalytic conformations of γ-CBL, decoupling its activity from acidic conditions. By further design, mutant M4 (M3-Q348D/M431K) with significantly improved thermostability was obtained. M4 was applied to three pH-control-free catalytic systems: achieving 360 g/L GABA in enzymatic catalysis (50 °C, 8 h), 219 g/L in whole-cell biocatalysis, and 60 g/L (1.71 g/L/h space-time yield) in high-cell-density fermentation. This study establishes an integrated computational/directed evolution loop engineering paradigm, enabling efficient, sustainable, and economically viable enzymatic GABA production by eliminating pH control requirements and enhancing process robustness.

01 Jan 2026·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Validation and quantitation of six neurotransmitters in rat plasma and brain using liquid chromatography quadrupole-time-of-flight mass spectrometry

Article

Author: Lasaosa, Maria ; Halquist, Matthew S ; Iqbal O'Meara, A M ; Furman, Amanda ; Reveil, Laerissa

Delirium is a cognitive dysfunction observed following sedation of critically injured patients. Neurotransmitters are endogenous chemical messengers that play key roles in a variety of essential nervous system functions, and their dysregulation is believed to contribute to the development of delirium. Monitoring neurotransmitters such as acetylcholine, dopamine, serotonin, gamma-aminobutyric acid, gamma-hydroxybutyric acid, and glutamic acid for biomarkers of delirium could improve our understanding of delirium pathogenesis and provide evidence for more efficacious treatments. However, current methods have limited scopes of analysis, require large sample volumes, or use complicated extraction methods. In this study, a novel, analytical approach was developed using liquid chromatography quadrupole-time-of-flight mass spectrometry to measure neurotransmitters in limited sample. This method was used to measure neurotransmitters in plasma and brain tissue samples taken from rats treated with a benzodiazepine sedative and opioid analgesic, a drug combination commonly prescribed in intensive care units and known to precipitate delirium. The analytical method was validated for selectivity, matrix effect, accuracy and precision, dilution integrity, and stability in rat plasma and partially validated in rat brain. The calibration curve ranged from 10 to 5000 ng/mL across the analytes. Within-run and between-run bias and precision of the LLOQ and QCs in plasma and brain were within 20 % and 15 %, respectively. Analytes were stable at 2 ºC and -80 ºC. Extraction recoveries from a simple protein precipitation ranged from 85 % to 133 %. The method was successfully applied to measure analytes in rat brain homogenates from a delirium model study.

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

30 Dec 2024

·www.pharmaindustrial-india.com

Immedica Announces Acquisition of Marinus Pharmaceuticals

Immedica Pharma and Marinus Pharmaceuticals have entered into an agreement and plan of merger under which Immedica has agreed to acquire Marinus, by means of a tender offer and subsequent merger. The acquisition complements and further strengthens Immedica’s global rare disease business by adding ZTALMY® (ganaxalone) oral suspension, CV, a neuroactive steroid gamma-aminobutyric acid (GABA)-A receptor positive modulator, approved by the U.S. Food and Drug Administration (FDA) in March 2022 for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two years of age and older. Adds global rights to ZTALMY, a commercial-stage rare neurology medicine approved by FDA, the European Commission (EC), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the National Medicines Product Administration (NMPA) in China with potential for further approvals worldwide. Accelerates Immedica’s growth into the North American market, providing an immediate revenue-generating rare disease product and an experienced commercial team upon closing of the transaction. Acquisition is expected to accelerate Immedica’s revenue growth, adding a commercial-stage asset in the United States, with the potential for further expansion globally. Immedica to commence a cash tender offer to acquire all issued and outstanding shares of Marinus for USD 0.55 per share, corresponding to an implied enterprise value of approximately USD 151 Million. Transaction is expected to close in Q1 2025. “The acquisition of Marinus represents a transformative step in Immedica’s journey to further strengthen our position as a leading rare disease company. By adding ZTALMY to our portfolio, we significantly strengthen our capabilities and expand our presence in the United States, marking a new chapter in our mission to deliver impactful therapies for underserved patient populations,” said Anders Edvell, MD PhD and Chief Executive Officer of Immedica. “Immedica is dedicated to addressing significant unmet medical needs in rare diseases, ensuring patients receive the innovative treatments they deserve. Within CDD, patients with refractory seizures face particularly challenging circumstances due to insufficiently effective existing therapies. The addition of ZTALMY allows us to offer a differentiated solution, with the potential to improve care and outcomes for these patients,” he concluded. “I am proud of the dedication and passion of our team at Marinus, which allowed us to deliver the first and only FDA-approved treatment for seizures associated with CDKL5 deficiency disorder in patients two years of age and older,” said Scott Braunstein, MD, Chairman and Chief Executive Officer of Marinus. “With a shared commitment to improving the lives of rare disease patients, this acquisition is expected to enable ZTALMY to make an even greater impact on patients, while providing meaningful value for Marinus’ stockholders,” Braunstein added.

Drug ApprovalAcquisition

100 Deals associated with Gamma-Aminobutyric Acid

External Link

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

R&D Status

Approved

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic Nephropathies	Preclinical	India	Lovely Professional University	02 Jul 2025

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