Adial Pharmaceuticals Expands Intellectual Property Portfolio with New U.S. Patent Granted for Genetic-Based Treatment of Alcohol and Opioid Use Disorders
Adial Pharmaceuticals (NASDAQ: ADIL) has secured a new U.S. patent (No. 12,274,692) for its investigational drug AD04, strengthening its intellectual property portfolio in addiction treatment. The patent, issued on April 15, 2025, covers a novel method of treating alcohol and opioid-related disorders using a precision medicine approach based on specific genetic markers.
The patent specifically claims treatment methods for patients with serotonin-related gene variations, including specific genotypes of HTR3A, HTR3B, and SLC6A4. The coverage extends to treating a broad spectrum of alcohol-related disorders, including alcohol-induced anxiety, bi-polar disorder, sexual dysfunction, sleep disorder, gambling disorder, and alcohol withdrawal.
Adial Pharmaceuticals (NASDAQ: ADIL) ha ottenuto un nuovo brevetto negli Stati Uniti (n. 12.274.692) per il suo farmaco sperimentale AD04, rafforzando il proprio portafoglio di proprietà intellettuale nel trattamento delle dipendenze. Il brevetto, rilasciato il 15 aprile 2025, riguarda un metodo innovativo per trattare disturbi legati all'alcol e agli oppioidi, basato su un approccio di medicina di precisione che utilizza specifici marcatori genetici.
Il brevetto copre in particolare metodi di trattamento per pazienti con variazioni genetiche correlate alla serotonina, inclusi genotipi specifici di HTR3A, HTR3B e SLC6A4. La protezione si estende al trattamento di un ampio spettro di disturbi legati all'alcol, come ansia indotta dall'alcol, disturbo bipolare, disfunzione sessuale, disturbi del sonno, gioco d'azzardo patologico e astinenza da alcol.
Adial Pharmaceuticals (NASDAQ: ADIL) ha obtenido una nueva patente en EE.UU. (n.º 12.274.692) para su fármaco en investigación AD04, fortaleciendo su cartera de propiedad intelectual en el tratamiento de adicciones. La patente, emitida el 15 de abril de 2025, cubre un método novedoso para tratar trastornos relacionados con el alcohol y los opioides mediante un enfoque de medicina de precisión basado en marcadores genéticos específicos.
La patente reclama específicamente métodos de tratamiento para pacientes con variaciones genéticas relacionadas con la serotonina, incluyendo genotipos específicos de HTR3A, HTR3B y SLC6A4. La cobertura se extiende al tratamiento de un amplio espectro de trastornos relacionados con el alcohol, como ansiedad inducida por alcohol, trastorno bipolar, disfunción sexual, trastornos del sueño, ludopatía y abstinencia alcohólica.
Adial Pharmaceuticals (NASDAQ: ADIL)는 실험 약물 AD04에 대해 미국 특허 번호 12,274,692를 획득하여 중독 치료 분야에서 지적 재산권 포트폴리오를 강화했습니다. 이 특허는 2025년 4월 15일에 발급되었으며, 특정 유전적 마커를 기반으로 한 정밀 의학 접근법을 사용하여 알코올 및 오피오이드 관련 장애를 치료하는 새로운 방법을 포함합니다.
특허는 특히 HTR3A, HTR3B, SLC6A4의 특정 유전자형을 포함한 세로토닌 관련 유전자 변이를 가진 환자에 대한 치료 방법을 청구합니다. 이 특허는 알코올 유발 불안, 양극성 장애, 성기능 장애, 수면 장애, 도박 장애, 알코올 금단 증상 등 광범위한 알코올 관련 장애 치료에도 적용됩니다.
Adial Pharmaceuticals (NASDAQ : ADIL) a obtenu un nouveau brevet américain (n° 12 274 692) pour son médicament expérimental AD04, renforçant ainsi son portefeuille de propriété intellectuelle dans le traitement des addictions. Le brevet, délivré le 15 avril 2025, couvre une méthode innovante de traitement des troubles liés à l’alcool et aux opioïdes, basée sur une approche de médecine de précision utilisant des marqueurs génétiques spécifiques.
Le brevet revendique spécifiquement des méthodes de traitement pour des patients présentant des variations génétiques liées à la sérotonine, incluant des génotypes spécifiques de HTR3A, HTR3B et SLC6A4. La couverture s’étend au traitement d’un large spectre de troubles liés à l’alcool, tels que l’anxiété induite par l’alcool, le trouble bipolaire, la dysfonction sexuelle, les troubles du sommeil, le trouble du jeu et le sevrage alcoolique.
Adial Pharmaceuticals (NASDAQ: ADIL) hat ein neues US-Patent (Nr. 12.274.692) für sein experimentelles Medikament AD04 erhalten und stärkt damit sein geistiges Eigentumsportfolio im Bereich der Suchtbehandlung. Das Patent, das am 15. April 2025 erteilt wurde, umfasst ein neuartiges Verfahren zur Behandlung von Alkohol- und Opioid-bedingten Störungen mittels eines Präzisionsmedizin-Ansatzes basierend auf spezifischen genetischen Markern.
Das Patent beansprucht speziell Behandlungsmethoden für Patienten mit serotoninbezogenen Genvariationen, einschließlich spezifischer Genotypen von HTR3A, HTR3B und SLC6A4. Der Schutz erstreckt sich auf die Behandlung eines breiten Spektrums alkoholbedingter Störungen, darunter alkoholinduzierte Angst, bipolare Störung, sexuelle Funktionsstörung, Schlafstörung, Glücksspielstörung und Alkoholentzug.
- New patent strengthens intellectual property protection for AD04 drug
- Patent covers broad spectrum of alcohol-related disorders, expanding potential market
- Precision medicine approach could enhance treatment efficacy through genetic targeting
- AD04 is still in clinical development phase, not yet FDA approved
- Success of genetic-based treatment approach remains to be proven in clinical trials
Insights
Adial's new patent significantly strengthens IP protection for AD04, covering personalized treatment of alcohol and opioid disorders based on specific genetic markers.
Adial's newly granted U.S. Patent #12,274,692 considerably enhances their intellectual property portfolio by protecting a precision medicine approach for addiction treatment. This patent goes beyond basic composition claims by covering the method of treating patients with specific genetic profiles, creating a dual barrier to competition through both the compound and patient selection methodology.
What's particularly valuable is the patent's expansive scope. It extends beyond basic alcohol use disorder to include alcohol-induced conditions such as anxiety, bipolar disorder, sexual dysfunction, sleep disorders, gambling disorder, and withdrawal symptoms. The additional coverage for opioid-related disorders further broadens the potential applications significantly.
The genetic specificity in this patent is impressive, identifying precise genotypes of HTR3A, HTR3B, and SLC6A4 (including the LL genotype of 5-HTTLPR) combined with variations in rs1150226, rs17614942, and rs1176713. This level of detail creates robust protection against potential workarounds by competitors.
From an IP strategy perspective, the patent's coverage of both diagnostic elements (genetic identification) and treatment protocols (dosing regimens) creates multiple layers of protection. Assuming a standard 20-year protection period from filing date, this patent likely provides market exclusivity well into the 2040s, offering substantial runway if AD04 achieves commercial success.
New patent enhances Adial's precision medicine strategy for addiction treatment, expanding potential applications while establishing barriers to competition.
This patent grant strategically positions Adial in the growing precision medicine space for addiction treatment. The specificity around genetic markers (HTR3A, HTR3B, SLC6A4) suggests their clinical approach is highly targeted, which could potentially yield better efficacy rates in genetically suitable patients compared to current one-size-fits-all treatments for addiction.
The expanded indication scope represents a significant market opportunity. The alcohol use disorder market alone affects millions globally, but by securing protection for both alcohol and opioid-related disorders, plus associated conditions like anxiety and sleep disorders, Adial has effectively widened their addressable market substantially.
This patent aligns perfectly with the industry's shift toward biomarker-driven treatment selection. The serotonin pathway targeted (through the specific genotypes mentioned) has established relevance in addiction mechanisms, giving scientific credibility to their approach.
From a competitive standpoint, the patent creates a significant entry barrier. Competitors would need to either target different genetic markers or use entirely different mechanisms of action to avoid infringement.
While this patent strengthens Adial's long-term commercial potential, it's important to recognize that it represents intellectual property protection for their approach rather than validation of clinical efficacy. The precision medicine strategy, though promising, also means Adial must develop both a genetic test and treatment, potentially adding complexity to their regulatory pathway. Nevertheless, this patent represents meaningful progress in their business strategy and enhances the potential value of their AD04 asset.
New patent covers a treatment method for a broad spectrum of alcohol-related disorders, including additional conditions associated with alcohol use
GLEN ALLEN, Va., May 01, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced patent number 12,274,692 was issued on April 15, 2025 by the United States Patent and Trademark Office (USPTO) covering a novel method of treating alcohol-related diseases and opioid-related disorders using AD04 in genetically identified patients.
This newly issued patent strengthens Adial’s intellectual property portfolio by covering the administration of AD04, the Company’s investigational drug, as a precision medicine approach for patients with specific genetic markers. The patent claims a method of treating addiction by administering a therapeutically effective amount of AD04 to patients with serotonin-related gene variations, including specific genotypes of HTR3A, HTR3B, and SLC6A4, such as the LL genotype of 5-HTTLPR in combination with variations in rs1150226, rs17614942, and rs1176713. The granted claims include specific genetic profiles associated with treatment efficacy and the corresponding dosing regimens. Specifically for AUD, the patent claims cover a method of treatment for a broad definition of alcohol related disorders including, but not limited to, disorders associated with alcohol use such as alcohol induced or associated anxiety, bi-polar, sexual dysfunction, sleep disorder, or gambling disorder as well as alcohol withdrawal.
“This patent represents yet another significant milestone for Adial Pharmaceuticals as we advance our mission to provide targeted treatments for individuals suffering from alcohol and opioid use disorders,” said Cary Claiborne, Chief Executive Officer of Adial Pharmaceuticals. “By identifying genetic markers associated with AD04 response, we are pioneering a precision medicine approach for AUD that has the potential to enhance treatment efficacy and improve patient outcomes. We remain committed to advancing AD04 through clinical development and regulatory pathways to address the urgent need for effective, personalized addiction treatments.”
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com.
If you are interested in exploring partnership opportunities with Adial, we invite you to reach out to us (BD@adialpharma.com) to discuss how our joint efforts can bring about positive change to the millions of patients who are struggling with addiction.
Forward-Looking Statements
This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding advancing the Company’s mission to provide targeted treatments for individuals suffering from alcohol and opioid use disorders; and identifying genetic markers associated with AD04 response having the potential to enhance treatment efficacy and improve patient outcomes for AUD. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, future AD04 trials supporting AUO 4’s ability to enhance treatment efficacy and improve patient outcomes for AUD; our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
Contact:
Crescendo Communications, LLC
David Waldman / Alexandra Schilt
Tel: 212-671-1020
Email: ADIL@crescendo-ir.com
FAQ
What is the significance of ADIL's new patent for alcohol and opioid treatment?
What genetic markers does Adial's new patent target for addiction treatment?
What conditions are covered by ADIL's new patent for AD04?
When was Adial Pharmaceuticals' new genetic treatment patent issued?
