Drugs in MeSH Category GABA Modulators

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	076955-001	Oct 12, 2004	AP	RX	No	No
Hikma	DIAZEPAM	diazepam	INJECTABLE;INJECTION	070311-001	Dec 16, 1985	AP	RX	No	No
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-001	Dec 20, 1985		DISCN	Yes	No
Norvium Bioscience	ALPRAZOLAM	alprazolam	TABLET;ORAL	074046-001	Oct 19, 1993		DISCN	No	No
Rafa Labs Ltd	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	midazolam hydrochloride	SOLUTION;INTRAMUSCULAR	216359-001	Aug 8, 2022		RX	Yes	Yes
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-004	Jan 17, 2003	AB	RX	Yes	Yes

GABA Modulators Market Analysis and Financial Projection

The market for GABA modulators is experiencing significant growth and innovation, driven by rising neurological disorder prevalence and advancements in receptor-targeted therapies. Here's a breakdown of key dynamics:

Market Overview and Growth Projections

• The GABA receptor drug market was valued at $1.5B in 2022 and is projected to reach $2.8B by 2030 (CAGR 8.5%)[1][5]. Revised estimates suggest a larger potential, with a $1.2B valuation in 2024 growing to $2.5B by 2033 (CAGR 9.2%)[5].
• North America dominates with >40% market share, fueled by major pharmaceutical players like Sage Therapeutics and Marinus Pharmaceuticals[5].

Key Growth Drivers:

• Rising global burden of neurological disorders (264M+ depression cases, 50M epilepsy patients)[5][8]
• Aging population driving demand for Alzheimer's/Parkinson's treatments
• Advancements in receptor subtype selectivity (e.g., α2/α3-targeted drugs)[8][12]

Pipeline Innovation

Over 25 companies are developing GABA modulators, with notable candidates:	Drug	Company	Mechanism	Stage	Indication
Ganaxolone	Marinus Pharmaceuticals	GABAA PAM	Pre-registration	CDKL5 deficiency seizures[1]
EMB-001	Embera NeuroTherapeutics	Cortisol/BDZ combo	Phase II/III	Smoking cessation[1]
ENX-102	Engrail Therapeutics	α2/α3/α5 PAM	Phase II	Generalized anxiety[8]
GT-002	Gabather	Tonic/phasic modulator	Preclinical → Phase I	Psychiatric disorders[2]

Patent Landscape Trends

Recent strategic IP developments focus on:

1. Subunit Selectivity
   • Sage Therapeutics: Neuroactive steroids targeting sedation/anesthesia pathways (US20240025942A1)[6]
   • Gabather: Dual EEG/fMRI-based claims for GT-002 in psychiatric disorders (2024 provisional patents)[2]
2. Novel Delivery Methods
   • Gene therapies like ETX101 (AAV vector for SCN1A upregulation)[8]
3. Repurposing Strategies
   • Gain Therapeutics: GBA/GALC modulators for Parkinson's and multiple sclerosis (PCT/IB2020 patents)[11]

Emerging Patent Classes:

• α5 NAMs for cognitive enhancement (US20190270734A1)[14]
• Combination therapies mitigating benzodiazepine tolerance[12]

Competitive Challenges

• R&D Costs: Average drug development cost exceeds $2.6B[5]
• Safety Hurdles: 30% trial attrition due to sedation/cognitive side effects[5][12]
• Bioequivalence Issues: Complex pharmacokinetics of extrasynaptic receptors[3][7]

Future Outlook

The sector shows strong potential with:

• $3.2B projected valuation by 2025 for receptor subtype-selective drugs[9]
• AI-driven drug discovery accelerating compound screening (30% faster vs traditional methods)[9]
• Partnerships like UCSF/Industry consortia for epileptic encephalopathy targets[13]

"The claims based on our EEG/fMRI study are novel and unexpected, giving Gabather a strong competitive advantage in next-gen neuropsychiatric drugs." – Michael-Robin Witt, CEO of Gabather AB[2]

Key Takeaway: The GABA modulator landscape is pivoting toward precision neuropharmacology, with subtype selectivity and biomarker-guided development emerging as critical differentiators. Success will depend on balancing efficacy with reduced CNS side effects through structural biology insights[7][10] and innovative IP strategies[2][6].

References

1. https://www.businesswire.com/news/home/20220210005812/en/GABA-Receptor-Agonists-Drug-Market-Research-Report-2022-Comprehensive-Insights-About-25-Companies-and-25-Pipeline-Drugs---ResearchAndMarkets.com
2. https://www.biospace.com/gabather-files-two-new-patent-applications-to-secure-novel-findings-on-the-effects-of-gt-002-for-the-treatment-of-psychiatric-disorders
3. https://pubmed.ncbi.nlm.nih.gov/37709943/
4. https://www.engrail.com/our-science/
5. https://www.verifiedmarketreports.com/product/gamma-aminobutyric-acid-gaba-receptor-market/
6. https://www.pharmaceutical-technology.com/data-insights/sage-therapeutics-files-patent-for-gaba-modulator-pharmaceutical-compositions-for-sedation-and-anesthesia/
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC9357065/
8. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1341472/full
9. https://github.com/kelttnandan9/Market-Research-Report-List-1/blob/main/gamma-aminobutyric-acid-gaba-receptor-agonist-market.md
10. https://pubmed.ncbi.nlm.nih.gov/31738537/
11. https://www.gaucherdisease.org/blog/gain-therapeutics-announces-issuance-of-two-new-pct-patents-covering-gba-and-galc-modulator-compounds-for-treatment-of-cns-disorders/
12. https://pubmed.ncbi.nlm.nih.gov/39240716/
13. https://otm.uic.edu/wp-content/uploads/sites/66/2022/06/Biomedical-Technology-Assets-UIC-2022-Updated-6-13-22-incl-rare-diseases.pdf
14. https://patents.google.com/patent/US20190270734A1/en