Pfizer Provides Update on Oral GLP-1 Receptor Agonist Danuglipron
Pfizer (NYSE: PFE) has announced the discontinuation of danuglipron, its oral GLP-1 receptor agonist being developed for chronic weight management. While dose-optimization studies of once-daily formulations met key pharmacokinetic objectives, the decision came after a participant experienced potential drug-induced liver injury, which resolved after discontinuing the treatment.
The studies involved over 1,400 participants, with liver enzyme elevations generally aligned with approved agents in the same class. Despite this setback, Pfizer remains committed to advancing treatments for cardiovascular and metabolic diseases, including obesity, through their oral GIPR antagonist candidate and other early-stage obesity programs.
Pfizer (NYSE: PFE) ha annunciato la sospensione di danuglipron, il suo agonista recettoriale GLP-1 orale sviluppato per la gestione del peso cronico. Sebbene gli studi di ottimizzazione della dose delle formulazioni da assumere una volta al giorno abbiano raggiunto obiettivi farmacocinetici chiave, la decisione è stata presa dopo che un partecipante ha mostrato un potenziale danno epatico indotto dal farmaco, che si è risolto dopo l'interruzione del trattamento.
Gli studi hanno coinvolto oltre 1.400 partecipanti, con elevazioni degli enzimi epatici generalmente in linea con gli agenti approvati nella stessa classe. Nonostante questo contrattempo, Pfizer rimane impegnata a sviluppare trattamenti per le malattie cardiovascolari e metaboliche, inclusa l'obesità, attraverso il loro candidato antagonista GIPR orale e altri programmi per l'obesità in fase iniziale.
Pfizer (NYSE: PFE) ha anunciado la suspensión de danuglipron, su agonista oral del receptor GLP-1 que se estaba desarrollando para la gestión del peso crónico. Aunque los estudios de optimización de dosis de formulaciones de una vez al día cumplieron con los objetivos farmacocinéticos clave, la decisión se tomó después de que un participante experimentara un posible daño hepático inducido por el fármaco, que se resolvió tras la interrupción del tratamiento.
Los estudios involucraron a más de 1,400 participantes, con elevaciones de enzimas hepáticas generalmente alineadas con los agentes aprobados en la misma clase. A pesar de este contratiempo, Pfizer sigue comprometida a avanzar en tratamientos para enfermedades cardiovasculares y metabólicas, incluida la obesidad, a través de su candidato antagonista GIPR oral y otros programas iniciales para la obesidad.
화이자 (NYSE: PFE)는 만성 체중 관리를 위해 개발 중인 경구 GLP-1 수용체 작용제 다누글리프론의 중단을 발표했습니다. 하루에 한 번 복용하는 제형의 용량 최적화 연구는 주요 약리학적 목표를 충족했지만, 한 참가자가 약물로 인한 간 손상을 경험한 후 치료를 중단한 결과 회복되었습니다.
이 연구에는 1,400명 이상의 참가자가 포함되었으며, 간 효소 상승은 일반적으로 동일한 계열의 승인된 약물과 일치했습니다. 이러한 좌절에도 불구하고 화이자는 비만을 포함한 심혈관 및 대사 질환 치료의 발전에 전념하고 있으며, 경구 GIPR 길항제 후보 및 기타 초기 비만 프로그램을 통해 이 목표를 계속 추진하고 있습니다.
Pfizer (NYSE: PFE) a annoncé l'arrêt de danuglipron, son agoniste oral du récepteur GLP-1 en cours de développement pour la gestion du poids chronique. Bien que les études d'optimisation de la dose des formulations à prendre une fois par jour aient atteint des objectifs pharmacocinétiques clés, la décision a été prise après qu'un participant a présenté un potentiel dommage hépatique induit par le médicament, qui s'est résolu après l'arrêt du traitement.
Les études ont impliqué plus de 1 400 participants, avec des élévations des enzymes hépatiques généralement alignées avec les agents approuvés dans la même classe. Malgré ce revers, Pfizer reste déterminée à faire progresser les traitements pour les maladies cardiovasculaires et métaboliques, y compris l'obésité, à travers leur candidat antagoniste GIPR oral et d'autres programmes précoces sur l'obésité.
Pfizer (NYSE: PFE) hat die Einstellung von Danuglipron, seinem oralen GLP-1-Rezeptoragonisten zur Behandlung von chronischer Gewichtskontrolle, bekannt gegeben. Obwohl die Dosisoptimierungsstudien der einmal täglich einzunehmenden Formulierungen wichtige pharmakokinetische Ziele erreicht haben, wurde die Entscheidung getroffen, nachdem ein Teilnehmer potenzielle medikamentenbedingte Leberschäden erlitten hatte, die nach Absetzen der Behandlung zurückgingen.
In den Studien waren über 1.400 Teilnehmer involviert, wobei die Erhöhungen der Leberenzyme im Allgemeinen mit genehmigten Mitteln derselben Klasse übereinstimmten. Trotz dieses Rückschlags bleibt Pfizer engagiert, Behandlungen für Herz-Kreislauf- und Stoffwechselerkrankungen, einschließlich Fettleibigkeit, voranzutreiben, durch ihren oralen GIPR-Antagonisten-Kandidaten und andere Programme zur Bekämpfung von Fettleibigkeit in der frühen Phase.
- Dose-optimization studies met key pharmacokinetic objectives
- Company maintains active development pipeline in obesity treatment
- Discontinuation of key weight management drug candidate
- Safety concern with potential drug-induced liver injury in trial participant
- Loss of potential market opportunity in competitive GLP-1 space
Insights
Pfizer's discontinuation of danuglipron represents a significant setback in the company's obesity treatment strategy. Despite once-daily formulations meeting key pharmacokinetic objectives with potential for competitive efficacy and tolerability, a single case of asymptomatic drug-induced liver injury led to the program's termination.
This decision is particularly impactful as danuglipron was positioned as Pfizer's leading candidate to enter the lucrative GLP-1/obesity market, which has become a major growth driver for competitors like Novo Nordisk and Eli Lilly. The oral administration route could have been a key differentiator against the injectable formulations currently dominating the market.
The language referring to "recent input from regulators" suggests significant regulatory concerns about the safety profile, despite the company noting that liver enzyme elevations across their 1,400-participant safety database were generally consistent with other approved GLP-1 medications. This likely indicates a very conservative regulatory approach to this drug class.
While Pfizer emphasizes continued commitment to obesity research through their oral GIPR antagonist candidate and earlier pipeline programs, this termination leaves them without an advanced clinical candidate in one of pharmaceuticals' most strategically important therapeutic areas. This creates a notable gap in Pfizer's near-term growth prospects, particularly as the company navigates declining COVID-related revenues.
Pfizer’s dose-optimization studies of once-daily formulations of danuglipron (NCT06567327 and NCT06568731) met key pharmacokinetic objectives and confirmed a formulation and dose with the potential to deliver a competitive efficacy and tolerability profile in Phase 3 testing, based on earlier studies of twice-daily danuglipron. While the overall frequency of liver enzyme elevations across the over 1,400 participant safety database of danuglipron is in-line with approved agents in the class, a single asymptomatic participant in one of the dose-optimization studies experienced potential drug-induced liver injury which resolved after discontinuation of danuglipron. After a review of the totality of information, including all clinical data generated to date for danuglipron and recent input from regulators, Pfizer has decided to discontinue development of the molecule.
“Cardiovascular and metabolic diseases including obesity remain important areas of unmet medical need, and we plan to continue applying our global capabilities to advance a pipeline of investigational treatments that have the potential to fill critical gaps in patient care, including continued development of our oral GIPR antagonist candidate and other earlier obesity programs,” said Chris Boshoff, MD, PhD, Chief Scientific Officer and President, Research and Development at Pfizer. “While we are disappointed to discontinue the development of danuglipron, we remain committed to evaluating and advancing promising programs in an effort to bring innovative new medicines to patients.”
Data from the danuglipron clinical development program will be presented at a scientific forum or submitted for publication in a peer-reviewed journal in the future.
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Disclosure Notice
The information contained in this release is as of April 14, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about, among other topics, Pfizer’s plans and pipeline of investigational products, including Pfizer’s plans for continued development of its oral GIPR antagonist candidate and other earlier obesity programs and their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; uncertainties regarding the future development of Pfizer’s oral GIPR antagonist candidate, other earlier obesity programs or any other product candidates, including whether or when Pfizer’s oral GIPR antagonist candidate, other earlier obesity programs or any such other product candidates will advance to future studies or phases of development; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications for any potential indications for Pfizer’s oral GIPR antagonist candidate, other earlier obesity programs or any other product candidates may be filed in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications, which will depend on a myriad of factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether Pfizer’s oral GIPR antagonist candidate, other earlier obesity programs or any such other product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety, and/or other matters that could affect the availability or commercial potential of Pfizer’s oral GIPR antagonist candidate, other earlier obesity programs or any such other product candidates; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the
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FAQ
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