辉瑞因肝安全问题暂停口服GLP-1药物Danuglipron的开发相关帖子：-动脉网

Pfizer Halts Oral GLP-1 Drug Danuglipron Development Amid Liver Safety Concerns Related posts:

GeneOnline 等信源发布 2025-04-15 14:48

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by Steven Chung

由史蒂文·钟

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Specifically, one participant experienced possible drug-induced liver injury, which resolved after stopping the medication. Image source: Getty Images

具体来说，其中一名参与者经历了可能的药物性肝损伤，停药后该损伤得到了解决。图片来源：Getty Images

北

York,

约克，

Pfizer Inc.

辉瑞公司

(NYSE: PFE) announced yesterday it discontinued development of danuglipron (

(NYSE: PFE) 昨日宣布停止开发 danuglipron（

PF-06882961

), an investigational oral GLP-1 receptor agonist intended for chronic weight management. The decision follows a comprehensive review of clinical data and recent regulatory feedback.

），一种用于慢性体重管理的在研口服GLP-1受体激动剂。该决定是在全面审查临床数据和最近的监管反馈后作出的。

Pfizer Ends Oral GLP-1 Drug Danuglipron Development Due to Liver Safety

辉瑞因肝安全性问题终止口服GLP-1药物Danuglipron的开发

Although Pfizer’s dose-optimization studies for once-daily

尽管辉瑞公司每日一次剂量优化研究

danuglipron

丹格列普隆

(

NCT06567327

and

和

NCT06568731

) successfully met pharmacokinetic objectives and identified a formulation with promising efficacy and tolerability for Phase 3 trials. A potential safety concern led to the program’s termination. Specifically, one participant experienced possible drug-induced liver injury, which resolved after stopping the medication.

）成功达到了药代动力学目标，并确定了一种在疗效和耐受性方面具有前景的配方用于第三阶段试验。一个潜在的安全问题导致了该计划的终止。具体来说，一名参与者经历了可能的药物引起的肝损伤，这在停药后得到了解决。

While the overall incidence of liver enzyme elevations across the .

虽然整个过程中肝酶升高的总体发生率。

1,400+

1400+

participant safety database aligned with existing approved treatments, the isolated event prompted heightened scrutiny.

参与者安全数据库与现有已批准的治疗方案保持一致，这一孤立事件引发了更严格的审查。

“Obesity and related metabolic disorders continue to represent significant unmet medical needs,”

“肥胖症和相关代谢紊乱仍然是未被满足的重要医疗需求，”

said

说

Dr. Chris Boshoff, Chief Scientific Officer and President of Research and Development at Pfizer. “While it’s disappointing to end development of danuglipron, we remain committed to advancing innovative therapies, including our oral GIPR antagonist candidate and other early-stage obesity programs.”

辉瑞公司首席科学官兼研发总裁克里斯·博索夫博士表示：“虽然结束丹那利普龙的开发令人失望，但我们仍然致力于推进创新疗法，包括我们的口服GIPR拮抗剂候选药物和其他早期肥胖症项目。”

Pfizer plans to present data from the danuglipron clinical program at a scientific conference or submit it for publication in a peer-reviewed journal.

辉瑞计划在科学会议上展示danuglipron临床项目的数据，或将其提交给同行评议的期刊发表。

The move marks a strategic shift in Pfizer’s metabolic disease pipeline. The company redirects its focus to alternative approaches in the competitive obesity treatment landscape.

这一举措标志着辉瑞在代谢疾病研发管线上的战略转变。该公司将其重心转向竞争激烈的肥胖症治疗领域的替代方案。

Rising Demand for GLP-1 Receptor Agonists in Obesity and Diabetes Care

肥胖症和糖尿病护理领域对GLP-1受体激动剂的需求不断增长

GLP-1 receptor agonists have become a cornerstone in the treatment of obesity and type 2 diabetes, driven by their ability to promote weight loss, improve glycemic control, and reduce cardiovascular risk. These drugs mimic the action of the natural hormone GLP-1, which helps regulate blood sugar and appetite.

GLP-1受体激动剂已成为治疗肥胖症和2型糖尿病的基石，其通过促进减重、改善血糖控制以及降低心血管风险的能力而备受关注。这些药物模拟了天然激素GLP-1的作用，有助于调节血糖和食欲。

With the global obesity epidemic showing no signs of slowing down, demand for effective and sustainable treatment options has surged. It created a multibillion-dollar market opportunity for pharmaceutical companies..

随着全球肥胖症的流行毫无放缓的迹象，对有效且可持续治疗方案的需求激增，这为制药公司创造了数十亿美元的市场机会。

Novo Nordisk Leverages Semaglutide to Lead the Market

诺和诺德利用司美格鲁肽引领市场领先地位

Danish pharmaceutical giant Novo Nordisk has led the way in this space with

丹麦制药巨头诺和诺德在这一领域处于领先地位，

semaglutide

司美格鲁肽

, a once-weekly injectable GLP-1 receptor agonist. It is marketed under the brand names Ozempic for type 2 diabetes and

，一种每周一次的注射型GLP-1受体激动剂。它以品牌名称Ozempic用于2型糖尿病，并且

Wegovy

韦哥维

for chronic weight management. Clinical trials have demonstrated significant weight reduction of up to 15% or more in some patients, along with notable improvements in blood glucose control. These results have helped propel semaglutide into widespread clinical use. This made Wegovy the first GLP-1 therapy specifically approved for weight loss in non-diabetic individuals..

用于慢性体重管理。临床试验表明，部分患者的体重显著减少了15%或更多，同时血糖控制也有明显改善。这些结果帮助司美格鲁肽在临床上得到广泛应用。这使得Wegovy成为首个专门获批用于非糖尿病患者减肥的GLP-1疗法。

Eli Lilly’s Tirzepatide Raises the Bar

礼来公司的替西帕肽提高了标准

Eli Lilly has further intensified the competition with

礼来进一步加剧了竞争

tirzepatide

替尔泊肽

, a dual GLP-1/GIP receptor agonist that has shown superior efficacy compared to semaglutide in head-to-head trials. Marketed as Mounjaro for diabetes and Zepbound for obesity, tirzepatide has demonstrated weight loss exceeding

，一种在头对头试验中显示出比司美鲁肽更优疗效的双重GLP-1/GIP受体激动剂。该药物作为Mounjaro用于糖尿病治疗，作为Zepbound用于肥胖症治疗，替尔泊肽展现出了显著的减重效果，超过了

20%

in some clinical studies. It redefines expectations for pharmacologic obesity treatment. Its strong clinical profile and rapid uptake have positioned Lilly as a major contender in the obesity therapeutics market.

在一些临床研究中。它重新定义了对药物治疗肥胖症的期望。其强大的临床表现和快速吸收使礼来公司成为肥胖症治疗市场的主要竞争者。

Pfizer’s Exit Reflects a Highly Competitive and Evolving Landscape

辉瑞的退出反映了竞争激烈且不断发展的格局

In this increasingly crowded and high-performing therapeutic class, the bar for safety and efficacy continues to rise. Pfizer’s decision to discontinue development of its oral GLP-1 receptor agonist danuglipron. The decision underscores the challenges of differentiating new entrants amid already strong clinical benchmarks.

在这个日益拥挤且高性能的治疗类别中，安全性和有效性的标准不断提高。辉瑞决定停止开发其口服GLP-1受体激动剂danuglipron。这一决定突显了在已有强大临床基准的情况下，新进入者面临的差异化挑战。

Despite promising pharmacokinetic data and competitive efficacy potential, the program was halted due to safety considerations and strategic portfolio prioritization. As the obesity treatment market continues to evolve, companies must balance innovation with regulatory rigor and commercial viability..

尽管药代动力学数据前景良好且疗效潜力具有竞争力，但该计划因安全考虑和战略组合优先级调整而被叫停。随着肥胖治疗市场的不断发展，企业必须在创新与监管严格性及商业可行性之间取得平衡。

Can New GLP-1 Contenders Disrupt the Weight-Loss Giants, Lilly and Novo, in the Battle for Market Dominance?

新的GLP-1竞争者能否在争夺市场主导地位的战斗中颠覆减肥巨头礼来和诺和？

2024 Tang Prize Celebrates Revolutionary Biopharma Discoveries, a Nod to Game-Changing Diabetes and Obesity Treatments

2024年唐奖表彰革命性生物制药发现，对改变游戏规则的糖尿病和肥胖症治疗表示认可。

Novo Nordisk Bets Big on CagriSema With A Heavyweight Move Planned for 2026

诺和诺德重磅押注CagriSema，计划2026年推出重要举措

NICE Approves First-Ever Daily Pill for Endometriosis Treatment

NICE批准了首个用于治疗子宫内膜异位症的每日口服药片

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礼来公司的Zepbound成为首个也是唯一一个获FDA批准用于治疗阻塞性睡眠呼吸暂停的减肥药物。