Grace Therapeutics Granted Sixth U.S. Patent Covering I.V. Dosing Regimen for GTx-104
Grace Therapeutics (NASDAQ:GRCE) has secured its sixth U.S. patent (No. 12,414,943) for GTx-104, covering the I.V. dosing regimen of its novel injectable nimodipine formulation. This new method of use patent extends the company's patent protection until 2043, complementing its existing five patents on composition that provide protection until 2037.
GTx-104 is being developed to address unmet needs in aSAH (aneurysmal subarachnoid hemorrhage) patients. The drug has received FDA Orphan Drug Designation, which will provide seven years of marketing exclusivity upon NDA approval. The patent specifically covers the dosing regimen used in the Phase 3 STRIVE-ON safety trial.
Grace Therapeutics (NASDAQ:GRCE) ha ottenuto il sesto brevetto statunitense (No. 12,414,943) per GTx-104, che copre il regime di dosaggio endovena della sua nuova formulazione iniettabile di nimodipina. Questo nuovo brevetto di uso estende la protezione brevettuale dell’azienda fino al 2043, integrando i cinque brevetti esistenti sulla composizione che proteggono fino al 2037.
GTx-104 viene sviluppato per rispondere alle esigenze non soddisfatte dei pazienti con aSAH (emorragia subaracnoidea aneurismatica). Il farmaco ha ricevuto la Designazione di Farmaco Orfano FDA, che fornirà sette anni di esclusività di commercializzazione una volta che l’NDA sarà approvata. Il brevetto copre specificamente il regime di dosaggio utilizzato nello studio di fase 3 STRIVE-ON sulla sicurezza.
Grace Therapeutics (NASDAQ:GRCE) ha obtenido su sexta patente estadounidense (No. 12,414,943) para GTx-104, que cubre el régimen de dosificación IV de su nueva formulación inyectable de nimodipina. Este nuevo título de uso extiende la protección de la empresa hasta 2043, complementando sus cinco patentes actuales sobre la composición, que protegen hasta 2037.
GTx-104 se desarrolla para abordar necesidades no cubiertas en pacientes con aSAH (hemorragia subaracnoidea aneurismática). El fármaco ha recibido la Designación de fármaco huérfano de la FDA, que proporcionará siete años de exclusividad de comercialización una vez que se apruebe el NDA. La patente cubre específicamente el régimen de dosificación utilizado en el ensayo de seguridad de fase 3 STRIVE-ON.
Grace Therapeutics (NASDAQ:GRCE)가 GTx-104에 대해 미국 특허 6건(번호 12,414,943)을 확보했으며, 이는 신규 주사 가능한 니모디핀 제형의 정맥 내 투여 요법을 다룬다. 이 새로운 사용 방법 특허는 회사를 2043년까지 특허 보호를 연장하며, 2037년까지 보호받는 조성물에 관한 기존의 다섯 건의 특허를 보완한다.
GTx-104는 aSAH(동맥류성 지주막하출혈) 환자의 미충족 요구를 다루기 위해 개발 중이다. 이 약물은 FDA 고아약 designation을 받아 NDA 승인이 이루어지면 7년의 마케팅 독점권을 받게 된다. 이 특허는 특히 3상 STRIVE-ON 안전성 시험에서 사용된 투여 요법을 다룬다.
Grace Therapeutics (NASDAQ:GRCE) a obtenu son sixième brevet américain (No. 12,414,943) pour GTx-104, couvrant le régime d'administration IV de sa nouvelle formulation injectable de nimodipine. Ce nouveau brevet d’utilisation étend la protection de l’entreprise jusqu’en 2043, en complément des cinq brevets existants sur la composition qui protègent jusqu’en 2037.
GTx-104 est développé pour répondre aux besoins non satisfaits des patients atteints d’aSAH (hémorragie subarachnoïdienne aneurysmatique). Le médicament a reçu la designation de médicament orphelin de la FDA, ce qui offrira sept ans d’exclusivité marketing après l’approbation NDA. Le brevet couvre spécifiquement le schéma posologique utilisé dans l’essai de sécurité de phase 3 STRIVE-ON.
Grace Therapeutics (NASDAQ:GRCE) hat seinen sechsten US-Patent (Nr. 12,414,943) für GTx-104 gesichert, der das intravenöse DosierungsRegime ihrer neuen injizierbaren Nimodipin-Formulierung abdeckt. Diese neue Nutzungsart-Patentschutzt verlängert den Patentenschutz des Unternehmens bis 2043 und ergänzt die bestehenden fünf Patente zur Zusammensetzung, die bis 2037 schützen.
GTx-104 wird entwickelt, um ungedeckte Bedürfnisse von aSAH-Patienten (aneurysmatische Subarachnoidalblutung) anzugehen. Das Arzneimittel hat die FDA Orphan Drug Designation erhalten, die nach der Zulassung des NDA sieben Jahre Marktexklusivität gewährt. Das Patent deckt speziell das Dosierungsregime ab, das in der Phase-3-Sicherheitsstudie STRIVE-ON verwendet wird.
Grace Therapeutics (NASDAQ:GRCE) حصلت على براءة الاختراع الأمريكية السادسة (رقم 12,414,943) لـ GTx-104، وتغطي نظام الجرعة الوريدي لصيغة nimodipine القابلة للحقن الجديدة. تمتد هذه البراءة لاستخدامٍ جديد حماية الشركة حتى 2043، وتكمل خمس براءات اختراع حالية تتعلق بالتركيبة وتوفر حماية حتى 2037.
يتم تطوير GTx-104 لمعالجة الاحتياجات غير الملباة لمرضى aSAH (نزف تحت العنكبوتية aneurysmal). تلقّى الدواء تصميم دواء يتيم من FDA، ما سيمنح سبع سنوات من حصرية السوق بمجرد الموافقة على NDA. البراءة تغطي تحديداً نظام الجرعة المستخدم في تجربة السلامة للمرحلة الثالثة STRIVE-ON.
Grace Therapeutics (NASDAQ:GRCE) 已为其新型注射用尼莫地平制剂的静脉给药方案获得第六项美国专利（No. 12,414,943），涉及 GTx-104。该使用方式新专利将公司的专利保护延长至2043，与现有的关于组成的五项专利共同保护至2037年。
GTx-104 正在开发，以满足 aSAH（动脉瘤性蛛网膜下腔出血）患者的未满足需求。该药已获得 FDA 的孤儿药 designation，获批 NDA 后将享有七年的市场独占期。该专利特别涵盖在第三阶段 STRIVE-ON 安全性试验中使用的给药方案。
- New patent extends protection until 2043, significantly longer than existing patents
- Secured FDA Orphan Drug Designation providing 7 years of marketing exclusivity
- Multi-layered IP protection with 6 total patents strengthens market position
- Successfully completed Phase 3 STRIVE-ON safety trial with proprietary dosing regimen
- FDA approval for NDA still pending
- Commercial success dependent on regulatory approval and market adoption
Insights
Grace's new method-of-use patent for GTx-104 extends protection to 2043, creating a stronger multi-layered IP fortress for their lead asset.
Grace Therapeutics has secured a significant intellectual property milestone with the grant of their sixth U.S. patent covering GTx-104, their injectable nimodipine formulation targeting aneurysmal subarachnoid hemorrhage (aSAH). This newly issued patent (U.S. Patent No. 12,414,943) is particularly noteworthy as it covers the specific IV dosing regimen used in their Phase 3 STRIVE-ON safety trial, adding method-of-use protection to their existing composition patents.
The strategic value of this patent cannot be overstated. While Grace already had five composition patents providing protection until 2037, this method-of-use patent extends their exclusivity window to 2043 - potentially adding six years of market protection. This creates a multi-layered IP fortress: composition patents protecting the formulation itself, method patents covering how it's administered, and FDA Orphan Drug Designation providing an additional seven years of marketing exclusivity upon approval.
This patent specifically protects the dosing regimen that would appear in the product label - a critical element for preventing generic competition. By securing protection for the actual administration protocol that physicians would follow, Grace has effectively blocked a common pathway competitors might use to work around composition patents. For a hospital-administered product like GTx-104, where precise dosing is essential, this protection is particularly valuable.
The extended timeline to 2043 significantly enhances the commercial potential of GTx-104, assuming FDA approval, by nearly ensuring almost two decades of market exclusivity - a remarkably long runway for generating returns in the pharmaceutical industry.
Grant of First Method of Use Patent Adds New Pillar to Grace’s Multi-layered Intellectual Property and Potential Market Exclusivity Protection
Patent Coverage Extended to 2043
PRINCETON, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for I.V. infusion to address significant unmet medical needs in aSAH patients, today announced that the U.S. Patent and Trademark Office has issued a U.S. Patent No. 12,414,943, titled “Nimodipine Parenteral Administration”. The new method of use patent, published on September 16, 2025, covers the dosing regimen for I.V. administration of nimodipine used in the Phase 3 STRIVE-ON safety trial for GTx-104.
Grace Therapeutics has established a multi-layered intellectual property estate for GTx-104, including five patents on the composition of the Company’s formulation of nimodipine, which provide patent protection to 2037. The new patent on the I.V. dosing regimen for GTx-104 strengthens the Company's intellectual property position and extends protection to 2043. Grace has also been granted Orphan Drug Designation from the FDA, which provides GTx-104 seven years of marketing exclusivity in United States upon FDA approval of the Company’s New Drug Application (NDA).
“We conducted extensive clinical work with our innovative GTx-104 formulation and dosing regimen and established the scientific bridge to oral nimodipine” said Prashant Kohli, Chief Executive Officer of Grace Therapeutics. “With patent coverage on the dosing regimen that would be included in the label for GTx-104, if approved by the FDA, we have added a new layer and extended the duration of protection on the proprietary work completed in our pharmacokinetic studies and the Phase 3 STRIVE-ON safety trial. We believe that if our NDA for GTx-104 is approved by the FDA, our strong U.S. and international patent estate will help to maximize the long-term market value of GTx-104 and correspondingly deliver value for our shareholders.”
About the STRIVE-ON Safety Trial
The STRIVE-ON safety trial (NCT05995405) was a prospective, randomized open-label trial of GTx-104 compared with oral nimodipine in patients hospitalized with aSAH. 50 patients were administered GTx-104 and 52 patients received oral nimodipine. The primary endpoint was the number of patients with at least one episode of clinically significant hypotension reasonably considered to be caused by the drug, and additional secondary endpoints included safety, clinical, and pharmacoeconomic outcomes. The trial met its primary endpoint, with patients receiving GTx-104 observed to have a
About aneurysmal Subarachnoid Hemorrhage (aSAH)
aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm in the brain. The result is aSAH, a relatively uncommon type of stroke that accounts for about
About GTx-104
GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for I.V. infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral I.V. infusion.
GTx-104 provides a convenient I.V. delivery of nimodipine in the Intensive Care Unit, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.
About Grace Therapeutics
Grace Therapeutics, Inc. (Grace Therapeutics or the Company) is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’ novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace Therapeutic’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics’ lead clinical asset, GTx-104, is an I.V. infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull.
For more information, please visit: www.gracetx.com.
Forward-Looking Statements
Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, forward-looking statements). Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Grace Therapeutics to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes," "belief," "expects," "intends," "anticipates," "estimates," "potential," "should," "may," "will," "plans," "continue," "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding, the future prospects of the Company’s GTx-104 drug candidate, the timing and the outcome of the FDA’s review of the Company’s NDA submission for GTx-104, benefits of GTx-104’s Orphan Drug Designation, GTx-104’s potential to bring enhanced treatment options to patients suffering from aSAH, GTx-104’s potential to be administered to improve the management of hypotension in patients with aSAH, the ability of GTx-104 to achieve a pharmacokinetic and safety profile similar to the oral form of nimodipine, GTx-104’s potential to achieve medical and pharmacoeconomic benefit, GTx-104’s commercial prospects, and the Company’s patent estate and its ability to extend exclusivity of GTx-104, are based upon Grace Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome of the Company’s NDA for GTx-104; (iii) changes to regulatory pathways; (iv) the Company’s ability to maintain effective patent rights and other intellectual property protection for its product candidates and (v) legislative, regulatory, political and economic developments. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in the "Special Note Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2025, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 filed with the Securities and Exchange Commission (SEC) and other documents that have been and will be filed by Grace Therapeutics from time to time with the SEC and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Grace Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws.
For more information, please contact:
Grace Therapeutics Contact:
Prashant Kohli
Chief Executive Officer
Tel: 609-322-1602
Email: info@gracetx.com
www.gracetx.com
Investor Relations:
LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com
FAQ
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