Jaguar Health Supports Evaluation of FDA-Approved Crofelemer to Address GI Side Effects of GLP-1 and Other Weight Loss Therapies: Files Patent Application with USPTO
Jaguar Health (NASDAQ:JAGX) has filed a provisional patent application with the USPTO for crofelemer to address gastrointestinal side effects associated with GLP-1 and other weight loss therapies. Crofelemer, FDA-approved under the brand name Mytesi for HIV-related diarrhea, has shown significant benefits in improving GI symptoms including diarrhea, abdominal pain, and bloating.
The application targets the growing market of GLP-1 therapies, projected to reach $56 billion globally by 2025 and grow at a 21% CAGR to $322 billion by 2034. GI disorders are reported in 40-70% of patients using GLP-1 receptor agonists, with rates up to 85% in some cases, often leading to dose limitations or discontinuations.
Jaguar Health (NASDAQ:JAGX) ha presentato una domanda di brevetto provvisorio presso l'USPTO per il crofelemere, mirato ad affrontare gli effetti collaterali gastrointestinali associati alle terapie di perdita di peso come GLP-1. Il crofelemere, approvato dalla FDA con il nome commerciale Mytesi per la diarrea correlata all'HIV, ha mostrato benefici significativi nel migliorare i sintomi gastrointestinali, inclusi diarrea, dolori addominali e gonfiore.
La domanda si rivolge al mercato in crescita delle terapie GLP-1, che si prevede raggiungerà 56 miliardi di dollari a livello globale entro il 2025 e crescerà a un CAGR del 21% fino a 322 miliardi di dollari entro il 2034. I disturbi gastrointestinali sono segnalati nel 40-70% dei pazienti che utilizzano agonisti del recettore GLP-1, con tassi che arrivano fino all'85% in alcuni casi, spesso portando a limitazioni di dosaggio o interruzioni.
Jaguar Health (NASDAQ:JAGX) ha presentado una solicitud de patente provisional ante la USPTO para el crofelemere con el fin de abordar los efectos secundarios gastrointestinales asociados con las terapias de pérdida de peso como GLP-1. El crofelemere, aprobado por la FDA bajo el nombre comercial Mytesi para la diarrea relacionada con el VIH, ha demostrado beneficios significativos en la mejora de los síntomas gastrointestinales, incluyendo diarrea, dolor abdominal y distensión abdominal.
La solicitud apunta al creciente mercado de las terapias GLP-1, que se proyecta alcanzará $56 mil millones a nivel mundial para 2025 y crecerá a una CAGR del 21% hasta $322 mil millones para 2034. Se informan trastornos gastrointestinales en el 40-70% de los pacientes que utilizan agonistas del receptor GLP-1, con tasas que alcanzan hasta el 85% en algunos casos, lo que a menudo lleva a limitaciones de dosis o interrupciones.
재구르 헬스 (NASDAQ:JAGX)는 GLP-1 및 기타 체중 감량 치료와 관련된 위장 부작용을 해결하기 위해 USPTO에 크로페레미어에 대한 임시 특허 출원을 했습니다. 크로페레미어는 HIV 관련 설사를 치료하기 위해 마이테시라는 상표명으로 FDA 승인을 받았으며, 설사, 복통, 팽만감 등 위장 증상을 개선하는 데 중요한 이점을 보였습니다.
이번 신청은 2025년까지 560억 달러에 이를 것으로 예상되는 성장하는 GLP-1 치료 시장을 목표로 하며, 2034년까지 3,220억 달러로 연평균 21% 성장할 것으로 예상됩니다. GLP-1 수용체 작용제를 사용하는 환자의 40-70%에서 위장 장애가 보고되고 있으며, 일부 경우에는 85%까지 이를 수 있으며, 이는 종종 용량 제한이나 치료 중단으로 이어집니다.
Jaguar Health (NASDAQ:JAGX) a déposé une demande de brevet provisoire auprès de l'USPTO concernant le crofelemère pour traiter les effets secondaires gastro-intestinaux associés aux thérapies de perte de poids comme le GLP-1. Le crofelemère, approuvé par la FDA sous le nom de marque Mytesi pour la diarrhée liée au VIH, a montré des avantages significatifs dans l'amélioration des symptômes GI, y compris la diarrhée, les douleurs abdominales et les ballonnements.
La demande vise le marché en croissance des thérapies GLP-1, qui devrait atteindre 56 milliards de dollars dans le monde d'ici 2025 et croître à un TCAC de 21% pour atteindre 322 milliards de dollars d'ici 2034. Des troubles gastro-intestinaux sont rapportés chez 40 à 70% des patients utilisant des agonistes des récepteurs GLP-1, avec des taux pouvant atteindre jusqu'à 85% dans certains cas, ce qui entraîne souvent des limitations de dosage ou des arrêts.
Jaguar Health (NASDAQ:JAGX) hat beim USPTO einen vorläufigen Patentantrag für Crofelemere eingereicht, um die gastrointestinalen Nebenwirkungen zu adressieren, die mit GLP-1 und anderen Gewichtverlusttherapien verbunden sind. Crofelemere, das unter dem Markennamen Mytesi von der FDA für mit HIV verbundenen Durchfall zugelassen ist, hat bedeutende Vorteile bei der Verbesserung von GI-Symptomen wie Durchfall, Bauchschmerzen und Blähungen gezeigt.
Der Antrag zielt auf den wachsenden Markt der GLP-1-Therapien ab, der bis 2025 voraussichtlich 56 Milliarden Dollar weltweit erreichen wird und mit einer jährlichen Wachstumsrate (CAGR) von 21% bis 322 Milliarden Dollar bis 2034 wachsen soll. GI-Störungen werden bei 40-70% der Patienten berichtet, die GLP-1-Rezeptoragonisten verwenden, mit Raten von bis zu 85% in einigen Fällen, was häufig zu Dosisbeschränkungen oder Abbrüchen führt.
- Patent application could expand crofelemer's market to include the rapidly growing GLP-1 therapy sector
- Target market projected to reach $322 billion by 2034 with 21% CAGR
- Addresses a significant medical need affecting up to 85% of GLP-1 therapy patients
- No clinical trial data yet available for crofelemer's effectiveness with GLP-1 therapies
- Patent application is still pending, with no guarantee of approval
Insights
This patent filing represents a calculated strategic pivot that could position Jaguar Health to capture value in the explosive GLP-1 market. The timing is particularly shrewd, as GI side effects remain the Achilles' heel of GLP-1 therapies, affecting
The key strategic advantages here are threefold: First, crofelemer is already FDA-approved for HIV-related diarrhea, potentially enabling a faster regulatory pathway through supplemental applications. Second, the patent application appears broadly written to cover both current and future incretin-based therapies, creating a wide moat for IP protection. Third, the drug's plant-based nature and established safety profile for chronic use could appeal to both prescribers and patients seeking long-term solutions.
However, several critical factors warrant attention: The provisional patent filing starts a 12-month clock for full patent applications and success isn't guaranteed. Additionally, while the
The broad patent claims covering both commercialized obesity drugs and developmental therapies indicate a sophisticated IP strategy that could position Jaguar as a key player in the GLP-1 ecosystem. If successful, this could transform the company from a niche player in HIV-related treatments to a significant contributor in the obesity treatment landscape.
Gastrointestinal disorders are the most frequently reported adverse effects during clinical trials of GLP-1 agonists; GI adverse events usually develop in 40
Crofelemer, approved by the FDA under the brand name Mytesi® for HIV-related diarrhea, has demonstrated a significant benefit in improving gastrointestinal symptoms, including diarrhea, abdominal pain and discomfort, incontinence, bloating and constipation, when studied in populations with HIV-related diarrhea, cancer therapy-related diarrhea, and IBS
Crofelemer could have a significant supportive impact on GLP-1 therapies, one of the fastest growing classes of drugs, estimated to be a
SAN FRANCISCO, CA / ACCESS Newswire / January 29, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced Napo's filing of a broad defining provisional patent application with the U.S. Patent and Trademark Office (USPTO) for crofelemer, Jaguar's novel plant-based FDA-approved gastrointestinal normalizing prescription drug, to mitigate the gastrointestinal side effects associated with glucagon-like peptide-1 (GLP-1) receptor agonists and antagonists, together with other incretin-based therapies including glucose-dependent insulinotropic polypeptide (GIP) agonists and antagonists, and glucagon-agonist drugs.
GLP-1 and GIP drugs are analogs for incretin hormones that are released by the gut and bind to receptors in the brain and gastrointestinal tract, suppressing appetite, which consequently leads to body weight loss.
"Gastrointestinal disorders were the most frequently reported adverse effects during clinical trials and real-world experience of GLP-1 receptor agonists, 2 such as semaglutide, tirzepatide, and liraglutide. GI adverse events usually develop in 40
About Crofelemer
Crofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities.
About the Jaguar Health Family of Companies
Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi ® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.
For more information about:
Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com
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Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that crofelemer could have a significant supportive impact on GLP-1 therapies, and Jaguar's expectation that crofelemer may have the potential to normalize specific GI side effects associated with obesity therapies, address patient comfort, and help patient's stay on their therapy. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
1 GLP-1 Analogues Market Outlook: Rapid Growth at
2 Sun F, Chai S, Yu K, Quan X, Yang Z, Wu S, Zhang Y, Ji L, Wang J, Shi L. Gastrointestinal adverse events of glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a systematic review and network meta-analysis. Diabetes Technol Ther. 2015;17(1):35-42. doi: 10.1089/dia.2014.0188
3 J Clin Med. 2022 Dec 24;12(1):145. Clinical Recommendations to Manage Gastrointestinal Adverse Events in Patients Treated with GLP-1 Receptor Agonists: A Multidisciplinary Expert Consensus
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SOURCE: Jaguar Health, Inc.
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FAQ
What is the projected market size for GLP-1 therapies that JAGX is targeting?
How common are GI side effects in patients using GLP-1 therapies that JAGX's crofelemer aims to treat?
What symptoms can JAGX's crofelemer potentially address in GLP-1 therapy patients?
What is the current FDA approval status of JAGX's crofelemer?
What patent protection has JAGX filed for crofelemer's use with GLP-1 therapies?
