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 Date01 Oct 2024

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

11,040

Literatures (Medical) associated with Gamma-Aminobutyric Acid

01 May 2025·Neural Regeneration Research

Decoding the nexus: branched-chain amino acids and their connection with sleep, circadian rhythms, and cardiometabolic health

Article

Author: Seugnet, Laurent ; Li, Hui

The sleep-wake cycle stands as an integrative process essential for sustaining optimal brain function and, either directly or indirectly, overall body health, encompassing metabolic and cardiovascular well-being. Given the heightened metabolic activity of the brain, there exists a considerable demand for nutrients in comparison to other organs. Among these, the branched-chain amino acids, comprising leucine, isoleucine, and valine, display distinctive significance, from their contribution to protein structure to their involvement in overall metabolism, especially in cerebral processes. Among the first amino acids that are released into circulation post-food intake, branched-chain amino acids assume a pivotal role in the regulation of protein synthesis, modulating insulin secretion and the amino acid sensing pathway of target of rapamycin. Branched-chain amino acids are key players in influencing the brain’s uptake of monoamine precursors, competing for a shared transporter. Beyond their involvement in protein synthesis, these amino acids contribute to the metabolic cycles of γ-aminobutyric acid and glutamate, as well as energy metabolism. Notably, they impact GABAergic neurons and the excitation/inhibition balance. The rhythmicity of branched-chain amino acids in plasma concentrations, observed over a 24-hour cycle and conserved in rodent models, is under circadian clock control. The mechanisms underlying those rhythms and the physiological consequences of their disruption are not fully understood. Disturbed sleep, obesity, diabetes, and cardiovascular diseases can elevate branched-chain amino acid concentrations or modify their oscillatory dynamics. The mechanisms driving these effects are currently the focal point of ongoing research efforts, since normalizing branched-chain amino acid levels has the ability to alleviate the severity of these pathologies. In this context, the Drosophila model, though underutilized, holds promise in shedding new light on these mechanisms. Initial findings indicate its potential to introduce novel concepts, particularly in elucidating the intricate connections between the circadian clock, sleep/wake, and metabolism. Consequently, the use and transport of branched-chain amino acids emerge as critical components and orchestrators in the web of interactions across multiple organs throughout the sleep/wake cycle. They could represent one of the so far elusive mechanisms connecting sleep patterns to metabolic and cardiovascular health, paving the way for potential therapeutic interventions.

01 Mar 2025·METABOLIC ENGINEERING

Developing a Bacillus licheniformis platform for de novo production of γ-aminobutyric acid and other glutamate-derived chemicals

Article

Author: He, Yihui ; Wang, Shiyi ; Wang, Feixiang ; Mao, Shufen ; Jia, Tianli ; Zhao, Yiwen ; Cai, Dongbo ; Wang, Dong ; Chen, Junyong ; Zhu, Jiang ; Chen, Shouwen

Microbial cell factories (MCFs) have emerged as a sustainable tool for the production of value-added biochemicals. However, developing high-performance MCFs remains a major challenge to fulfill the burgeoning demands of global markets. This study aimed to establish the B. licheniformis cell factory for the cost-effective production of glutamate-derived chemicals by modular metabolic engineering. Initially, the glutamate decarboxylase from E. coli was introduced into B. licheniformis DW2 to construct the artificial γ-aminobutyric acid (GABA) pathway. By systematically optimizing the central metabolic pathway, boosting the L-Glu synthesis pathway and improving the cofactor NADPH supply, the strain G35/pHY-P_r5u12-gadB^E89Q/H465A achieved a remarkable yield of 62.9 g/L of GABA in a 5-L bioreactor, representing the highest yield of 0.5 g/g glucose with a significant 49.3-fold increase. Remarkably, bioinformatics analyses and function verification identified the putative glyoxylate to glycolic acid synthesis pathway and KipR, an inhibitor of the glyoxylate cycle, as the rate-limiting steps in GABA production. Additionally, a versatile and robust platform using engineered B. licheniformis for efficient production of diverse glutamate-derived chemicals was established and the titer of 5-aminolevulinic acid, heme and indigoidine was improved by 5.3-, 4.7- and 1.9-fold, respectively. This study not only facilitates extensive application of B. licheniformis for chemical production, but also sheds light on research to improve the performance of other MCFs.

01 Feb 2025·NEUROCHEMICAL RESEARCH

Nicotinamide and Nicotinoyl-Gamma-Aminobutyric Acid as Neuroprotective Agents Against Type 1 Diabetes-Induced Nervous System Impairments in Rats

Article

Author: Kuchmerovska, Tamara ; Savosko, Serhiy ; Pryvrotska, Iryna ; Yanitska, Lesya ; Tykhonenko, Tetiana

Diabetes is a multifunctional chronic disease that affects both the central and/or peripheral nervous systems. This study assessed whether nicotinamide (NAm) or conjugate of nicotinic acid with gamma-aminobutyric acid (N-GABA) could be potential neuroprotective agents against type 1 diabetes (T1D)-induced nervous system impairments in rats. After six weeks of T1D, induced by streptozotocin, nonlinear male Wistar rats were treated for two weeks with NAm (100 mg/kg, i. p.) or N-GABA (55 mg/kg, i. p.). Expression levels of myelin basic protein (MBP) were analyzed by immunoblotting. Polyol pathway parameters of the sciatic nerves were assessed spectrophotometrically, and their structure was examined histologically. NAm had no effect on blood glucose or body weight in T1D, while N-GABA reduced glucose by 1.5-fold. N-GABA also increased MBP expression by 1.48-fold, enhancing neuronal myelination, while NAm showed no such effect. Activation of the polyol pathway was observed in the T1D sciatic nerves. Both compounds decreased sorbitol content and aldose reductase activity, thereby alleviating changes similar to primary degeneration in the sciatic nerves and preventing peripheral neuropathy development. These results demonstrate that NAm and, more notably, N-GABA may exert neuroprotective effects against T1D-induced nervous system impairments by increasing MBP expression levels, improving myelination processes in the brain, inhibiting the polyol pathway, and partially restoring morphometric parameters in the sciatic nerves. This suggests their potential therapeutic efficacy as promising agents for the prevention of T1D-induced nervous system alterations.

News (Medical) associated with Gamma-Aminobutyric Acid

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

25 Nov 2024

·www.prnewswire.com

Major Depressive Disorder Market to Register Immense Growth by 2034 Owing to a Robust Pipeline | DelveInsight

With the anticipated introduction of new treatments such as COMP360 (COMPASS Pathways), Zuranolone (SAGE Therapeutics/Biogen), LY03005 (Luye Pharma), REL-1017 (Relmada Therapeutics), Seltorexant (Minerva Neurosciences/Janssen Pharmaceutical), ABV-1504 (BioLite/ABVC BioPharma), and other and increasing disease awareness, it's reasonable to expect a significant transformation in the major depressive disorder market in the coming years. LAS VEGAS, Nov. 25, 2024 /PRNewswire/ -- Major depressive disorder (MDD), commonly referred to as depression, is a serious medical condition that affects a person's mood, behavior, thinking, and physical well-being. It is different from the temporary feelings of sadness that everyone experiences and should not be confused with the deep grief following the loss of a loved one. MDD is typically a recurrent and episodic condition, meaning that someone who has experienced depression and recovered is likely to face additional episodes, often within 2 to 3 years. As per DelveInsight analysis, the total diagnosed prevalent cases of MDD in the 7MM were found to be approximately 44 million cases in 2023, which is expected to increase during the forecast period (2024–2034). Among the severity-specific diagnosed prevalent cases of MDD, the highest prevalence was observed in moderate cases accounting for approximately 17 million cases in the 7MM in 2023 followed by severe cases and mild cases. Major depressive disorder can be addressed through several treatment approaches, including pharmacological interventions, psychotherapy, interventional methods, and lifestyle changes. Initial treatment often involves either medication, psychotherapy, or a combination of both, with combined therapy proving more effective than using either alone. For severe cases of major depression, electroconvulsive therapy is the most effective option. The current range of recommended pharmacological treatments for major depressive disorder primarily includes antidepressants such as monoamines, tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), and selective reuptake inhibitors, including medications like VRAYLAR, BRINTELLIX (now TRINTELLIX), SPRAVATO, REXULTI, and FETZIMA. In the upcoming major depressive disorder treatment market landscape, there are a plethora of companies investigating agents for use in major depressive disorder which includes Sage Therapeutics, Relmada Therapeutics, Johnson & Johnson Services, Inc., Biogen, COMPASS Pathways, Luye Pharma, and others. Many more pharma companies are conducting clinical trials for therapies for major depressive disorder. To know more about upcoming major depressive disorder therapies showing positive results, visit @ Drugs for Major Depressive Disorder Treatment DelveInsight estimates that the market size for major depressive disorder is expected to grow from USD 7.1 billion in 2023 with a significant CAGR by 2034. The disease awareness and the emergence of new products in the pipeline will add to the market growth in the future. In addition, persistently rising cases of MDD in the forecast period will contribute to the rise in the MDD treatment market. The current pipeline for major depressive disorder includes a range of drugs with diverse mechanisms of action (MoA). COMP360 (COMPASS Pathways) , Zuranolone (SAGE Therapeutics/Biogen) , LY03005 (Luye Pharma) , REL-1017 (Relmada Therapeutics) , seltorexant (Minerva Neurosciences/Janssen Pharmaceutical) , ABV-1504 (BioLite/ABVC BioPharma), and some others are the most promising drugs of this indication. Ongoing research and current trials have the potential to change the MDD market. Keen to know how the MDD market will evolve by 2034? Find out @ Major Depressive Disorder Market Report The potential for effective major depressive disorder treatment in the future is expected to grow with the addition of numerous drugs to the pipeline of new therapeutics. Currently, a variety of candidate drugs for the treatment of major depressive disorder are being tested in various clinical trials, with some showing positive results. Any drug approved with increased safety and efficacy is expected to cause significant changes in the overall major depressive disorder market. Now, let's examine the pipeline therapies under investigation for major depressive disorder COMP360: COMPASS Pathways Phase III COMPASS Pathways is investigating the use of its experimental psilocybin therapy, COMP360, for treating serious mental health conditions like major depressive disorder. COMP360 is a synthesized version of psilocybin, the active compound found in certain "magic mushrooms," and is administered alongside psychological support. Psilocybin has shown promise in therapeutic applications, and COMP360 has been granted Breakthrough Therapy status by the US FDA as well as an Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Currently, COMPASS Pathways is running a Phase II trial for MDD, with a Phase III trial underway in partnership with Massachusetts General Hospital to further explore its potential in meeting mental health treatment needs. The company is anticipated to release top-line data from two key trials, COMP005 and COMP006, by the fourth quarter of 2024 and mid-2025, respectively, for the treatment of TRD. Zuranolone: SAGE Therapeutics/Biogen Phase III Zuranolone, being developed by SAGE Therapeutics and Biogen, is a next-generation oral, highly potent, and selective positive allosteric modulator, designed for specific targeting of synaptic and extrasynaptic GABAA receptors. The binding sites for neuroactive steroids (NASs) are different from those for GABA, benzodiazepines, and barbiturates. The GABA system, which is the primary inhibitory signaling pathway in the brain and central nervous system (CNS), plays a key role in regulating CNS function. SAGE-217 is currently in phase III clinical development for major depressive disorder and is being evaluated through the LANDSCAPE and NEST clinical trial programs, which include multiple studies involving thousands of participants, with varying dosing regimens, clinical endpoints, and treatment approaches. In February 2023, the US FDA accepted the New Drug Application (NDA) for zuranolone in the treatment of MDD. However, in August 2023, the FDA issued a Complete Response Letter (CRL) regarding the NDA for zuranolone for treating adults with MDD. Sage and Biogen are now assessing the feedback and determining their next steps. LY03005: Luye Pharma LY03005, developed by Luye Pharma, is one of the company's key products in the CNS therapeutic space. It is their exclusive extended-release tablet formulation of ansofaxine hydrochloride, a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI) designed for treating major depressive disorder. LY03005 aims to offer improved efficacy and fewer side effects compared to conventional antidepressants like SSRIs and SNRIs. Ansofaxine, a prodrug of desvenlafaxine, strongly inhibits dopamine reuptake in addition to serotonin and norepinephrine, demonstrating superior efficacy in clinical trials. In March 2020, the US FDA accepted the NDA submission for LY03005, which is currently in Phase III pivotal clinical trials for MDD treatment. Seltorexant: Minerva Neurosciences/Janssen Pharmaceutical Phase III Seltorexant, developed by Minerva Neurosciences and Janssen Pharmaceutical, is a selective orexin-2 receptor antagonist intended as an adjunctive treatment for major depressive disorder and for managing insomnia. It is the most advanced ORX2-specific molecule in clinical development, acting as an antagonist by binding to its receptor. Seltorexant is being studied for two main uses: insomnia without psychiatric disorders and MDD in patients who do not respond adequately to SSRIs or SNRIs. In May 2024, Johnson & Johnson reported positive topline results from the pivotal Phase III MDD3001 trial, which assessed its efficacy and safety as an add-on therapy to antidepressants in adults and elderly MDD patients. Discover which therapies are expected to grab major MDD market share @ New Treatments for Major Depressive Disorder REL-1017: Relmada Therapeutics Phase III REL-1017, being developed by Relmada Therapeutics, is a novel chemical entity (NCE) and an NMDA receptor (NMDAR) channel blocker that specifically targets overactive channels while preserving normal glutamatergic neurotransmission. The U.S. FDA has granted it Fast Track Designation as an immunotherapy for treating major depressive disorder. In a Phase II trial, REL-1017 exhibited rapid, strong, and lasting antidepressant effects, with statistically significant improvements over placebo in depression measures. The study also indicated a favorable safety, tolerability, and pharmacokinetic profile for the drug. Currently, it is in late-stage development for MDD, being tested in Phase III trials for both adjunctive and monotherapy. In June 2024, Relmada published clinical data from the Reliance I Study. The company is actively enrolling patients in ongoing trials for REL-1017, including Reliance II (Study 302), with top-line results expected in the latter half of 2024, and Relight (Study 304), which is anticipated to provide results about six months after the completion of Study 302. ABV-1504: ABVC BioPharma Phase II ABV-1504, developed by ABVC BioPharma, features PDC-1421 as its active ingredient and is classified as a botanical investigational new drug. Through its subsidiary BioLite, ABVC has completed a Phase II trial of ABV-1504, a botanical Norepinephrine Transporter (NET) inhibitor. This trial, conducted at Stanford University, showed that the PDC-1421 capsule was safe and well-tolerated among six enrolled adult patients. Both low and high doses of PDC-1421 successfully achieved the study's primary endpoints, showing a necessary 40% improvement in ADHD-RS-IV test scores. In April 2023, PDC-1421 was awarded a US patent (US 11,554,154 B2) for the treatment of Major Depressive Disorder (MDD). The drug has also completed a Phase II trial in MDD patients, and the company intends to hold an End of Phase II (EOP II) meeting with the FDA in the near future. Itruvone (PH10): VistaGen Therapeutics Phase II Itruvone (PH10), being developed by VistaGen Therapeutics, is an investigational first-in-class synthetic neurosteroid that is odorless and fast-acting, showing promise for various neuropsychiatric conditions related to depression and suicidal thoughts. VistaGen is focusing on PH10 as a potential quick-acting, non-sedating, and non-addictive treatment for MDD that patients can conveniently self-administer at home. When self-administered, a microgram-level dose of PH10 sprayed into the nose interacts with nasal chemosensory receptors, activating brain neural circuits to produce rapid antidepressant effects without the side effects, systemic exposure, or safety issues associated with FDA-approved treatments for MDD, such as oral antidepressants and esketamine. After successfully completing Phase IIa trials for MDD, VistaGen is now gearing up for the planned Phase IIb clinical development of PH10 for this condition. Moreover, in December 2022, PH10 received fast-track designation from the US FDA. LPCN 1154: Lipocine Phase II LPCN 1154, developed by Lipocine, is an oral formulation of brexanolone designed for rapid relief of postpartum depression. Its active ingredient is a naturally occurring positive allosteric modulator of the GABAa receptor. This medication is intended to provide an "at-home" treatment option, making it more accessible than the current standard care, which involves invasive procedures and hospitalization. In September 2022, the FDA approved Lipocine's proposal to demonstrate the efficacy of LPCN 1154 through a single pivotal pharmacokinetic bridge to the approved IV infusion of brexanolone via a 505(b)(2) NDA submission. In June 2024, Lipocine announced positive topline results from a pivotal pharmacokinetic study, confirming that LPCN 1154 is bioequivalent to IV brexanolone for PPD treatment. Lipocine aims to submit the NDA by the end of the fourth quarter of 2024. Discover more about drugs for major depressive disorder in development @ Major Depressive Disorder Clinical Trials DelveInsight's latest published market report titled as Major Depressive Disorder Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the major depressive disorder country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The major depressive disorder market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of MDD Gender-specific Diagnosed Prevalent Cases of MDD Severity-specific Diagnosed Prevalent Cases of MDD The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM major depressive disorder market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this major depressive disorder market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the major depressive disorder market. Also, stay abreast of the mitigating factors to improve your market position in the major depressive disorder therapeutic space. Related Reports Major Depressive Disorder Pipeline Major Depressive Disorder Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key major depressive disorder companies, including GH Research, Praxis Precision Medicines, AbbVie, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals, among others. Treatment-Resistant Depression Market Treatment-Resistant Depression Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key TRD companies, including Navitor Pharmaceuticals, Supernus Pharmaceuti, Novartis, Relmada Therapeutics, Beckley Psytech, COMPASS Pathways, Axsome Therapeutics, Celon Pharma, among others. Treatment-Resistant Depression Pipeline Treatment-Resistant Depression Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key treatment-resistant depression companies, including Axsome Therapeutics, COMPASS Pathways, Merck Sharp & Dohme Corp., Navitor Pharmaceuticals, Inc., Taisho Pharmaceutical Co., Ltd., GH Research Limited, Novartis Pharmaceuticals, Reckitt Benckiser LLC, Relmada Therapeutics, Inc., SAGE Therapeutics, Navitor Pharmaceuticals, Sumitomo Dainippon Pharma, Alkermes, AbbVie, Janssen Pharmaceuticals, Celon Pharma, ACADIA Pharmaceuticals, Pherin Pharmaceuticals, ATAI Life Sciences, among others. Postpartum Depression Market Postpartum Depression Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key postpartum depression companies, including Sage Therapeutics, Epharmix, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 3Clinical ResultFast TrackBreakthrough Therapy

15 Nov 2024

·www.diamyd.com

Conference on the future of Type 1 Diabetes screening organized as part of the ASSET partnership coordinated by Diamyd Medical

As part of the ASSET innovation partnership led by Diamyd Medical, the Leading Healthcare Foundation organizes a conference on November 26, 2024, in Stockholm, Sweden, on the future of Type 1 Diabetes screening and treatment. The conference is co-sponsored by Sanofi. The event gathers key stakeholders, including patient organizations, healthcare professionals, researchers, and regulators, to explore the practical implementation of precision and preventive medicine in Type 1 Diabetes care. The conference will feature a keynote lecture by Prof. Chantal Mathieu, President of the European Association for the Study of Diabetes (EASD), and leading expert in diabetes care, who will discuss ongoing screening initiatives and guidelines in Europe. Additionally, two panel discussions will bring together patient and professional organizations, clinicians, regulators and policymakers. These discussions will center on the ethical, regulatory and policy requirements needed to integrate new screening technologies and innovative precision medicine therapies into the healthcare system. “Together with our ASSET partners and Sanofi, we are excited to expand the conversation on how early diagnosis and innovative approaches in precision medicine can transform Type 1 Diabetes care,” says Ulf Hannelius, CEO of Diamyd Medical. “By working together, we can drive the changes needed to make early diagnosis and precision treatment for Type 1 Diabetes a reality.” For more details and to register for the event, please visit https://leadinghealthcare.se/kalendern/framtidens-screening-konferens/. About ASSET The innovation milieu ASSET (AI for Sustainable Prevention of Autoimmunity in the Society) is an industry-healthcare partnership including Mainly AI, Lund University, Sahlgrenska University Hospital, Örebro University Hospital, The Swedish National Diabetes Register, Leading Health Care Foundation and Diamyd Medical, project coordinator. The project started in September 2021, has a duration of five years, and is financed by the Swedish innovation agency VINNOVA. ASSET has three main goals: Predict, Prevent and Implement. Predict: evaluate new algorithms based on Artificial Intelligence (AI) to be able to assess the individual risk of developing Type 1 Diabetes (T1D), and the likelihood of responding to different treatments. Data from cohort studies such as TEDDY (The Environmental Determinants of Diabetes in the Young), from Diamyd Medical's clinical trials with Diamyd® and from sources such as the National Diabetes Registry will constitute the initial training dataset for the algorithm. T1D will form the pilot project for the program, but the goal is extending the functionality to other indications including other autoimmune diseases that are strongly linked to T1D such as celiac disease (gluten intolerance) and autoimmune thyroiditis (inflammatory disease of the thyroid gland). Prevent: ASSET aims to be a test-bed for clinical development, with a pilot trial ongoing testing a precision medicine approach to early stage T1D. Implement: ASSET will study organizational, economic, and legal prerequisites and consequences of applying the approach as a tool for precision health in the Swedish health care system. The goal is to proactively manage obstacles that can slow down the implementation and spread of the innovations in the healthcare system. Website: https://www.asset.healthcare.se About Diamyd Medical Diamyd Medical develops precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd® is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production that has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 1, 2 and 3 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: ulf.hannelius@diamyd.com Diamyd Medical AB (publ) Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68 E-mail: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com The information was provided by the contact person above, for publication on November 15, 2024, 09:55 CET. Attachments: PDF version

Phase 2Orphan DrugFast Track

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	CN	Tianjin Lisheng Pharmaceutical Co., Ltd.	01 Jan 1981
Intracranial Arteriosclerosis	CN	Tianjin Lisheng Pharmaceutical Co., Ltd.	01 Jan 1981
Stroke	CN	Tianjin Lisheng Pharmaceutical Co., Ltd.	01 Jan 1981
Brain Injury, Chronic	JP	Alfresa Pharma Corp.	22 Nov 1961

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAI2023	Not Applicable	Glioblastoma	-	γ-aminobutyric acid (Female mice)	jlvsscnmzq(cfgucwzdhy) = hemelzqugr qdgbnjbdfs (oyazumdrrn )	-	01 May 2023
				γ-aminobutyric acid (Male mice)	jlvsscnmzq(cfgucwzdhy) = fwiieobmve qdgbnjbdfs (oyazumdrrn )
SNMMI2021	Not Applicable	-	-	[18F]GATT-34	srfmyjrnuc(ieimhuertz) = wihmyvbfmr ngkqelaedw (uyampazszh ) View more	-	18 May 2021
				[18F]GATT-44	srfmyjrnuc(ieimhuertz) = gidpzswdsc ngkqelaedw (uyampazszh ) View more
SFN2006	Not Applicable	Syncope, Vasovagal	-	Bicuculline methiodide (BMI)	thohgsumua(iskfunhtkf) = rgwqavrsbx dswrlumyoy (gfqxpjtglr, 0.6)	-	18 Oct 2006
SFN2004	Not Applicable	-	-	Bicuculline methiodide	mvgxiiomyl(wjvyqwczkt) = tmedoaerva hlkbqnkdqk (ciuepmpnsz ) View more	-	27 Oct 2004
SFN2003	Not Applicable	-	-	Muscimol	msqvmovmbr(tdocxjynkn) = nuugkisuih oqciiawmdo (gwlqvrbirz ) View more	-	08 Nov 2003
				GABA (Light)	msqvmovmbr(tdocxjynkn) = awlpmizvgy oqciiawmdo (gwlqvrbirz ) View more
SFN2002	Not Applicable	-	-	GABA-A antagonist bicuculline	vqgzelanpk(pqlmadgsbu) = yazdiolkyf pxuxyjdxvw (jelztdbhil )	-	03 Nov 2002
				GLY antagonist strychnine	vqgzelanpk(pqlmadgsbu) = vpmcrgzust pxuxyjdxvw (jelztdbhil )
SFN2001	Not Applicable	Sleep	-	Muscimol	ijysmpixxg(ftyxajqjdg) = A small decrease in PGO density during AS was observed following the injection of muscimol ntyjcvmqcm (iycntzpivd )	-	13 Nov 2001

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