Avexitide

iStock, LangPhoto Nearly 100 biotechs went public amid the industry’s IPO frenzy in 2021, driven by an influx of pandemic-driven investments. But many of those companies have little to show investors. Four years ago, as a killer virus was sweeping across the globe and forcing entire countries to shut down, biopharma was in the midst of a goldrush . Money was flowing into the industry at record levels. Investments spread from helping find treatments and vaccines for COVID-19 to the broader life sciences industry. This led to a pile up of initial public offerings among biotechs in 2021. In total, the year saw 99 biotechs hit the public markets, by BioSpace ’s tally, raising $15.6 billion— more than in 2023 and 2024 combined . The boom was a “masterclass in what happens when scientific momentum meets monetary excess,” Mayo Venture Partner Audrey Greenberg told BioSpace in an email. “At the time, I remember thinking it felt like biotech’s version of speed dating: everyone wanted to fall in love with the next Moderna, and no one wanted to miss the match.” But, as Greenberg said, “gravity always returns.” Fast forward to now, and many of those companies that reached the public markets have little to show investors. Some have even gone bankrupt . This downturn “revealed how financial momentum can outpace biological maturity,” Stella Vnook, CEO of drug delivery biotech Likarda and a serial entrepreneur, told BioSpace in an email. During the pandemic boom, companies went public largely on the basis of their science, she explained, without mature data or infrastructure to back it up. While difficult, the market contraction that has since occurred “forced the sector to return to fundamentals,” according to Vnook. Companies now have to show clinical validation, quality execution and operational discipline to attract investors. Vnook insisted, though, that the current state of the industry is “not a collapse.” “It’s a recalibration,” she said. .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to BioPharm Executive! Market insights, trending business and policy stories for biopharma leaders hbspt.forms.create({ region: "na1", portalId: "4413123", formId: "7c139b3c-ff0b-44e0-bffe-f449801dca59", onFormSubmitted: function($form, data) { window.dataLayer = window.dataLayer || []; window.dataLayer.push({ 'event': 'GTMevent', 'event_name': 'newsletter_sign_up' }); } }); For Mike Perrone, managing director and healthcare specialist at the investment firm Baird, the 2021 IPO rush left what he called a “logical gap” in the industry. Scores of companies entered the public market before they were ready to, resulting in what Perrone called a “pull-forward of future IPOs.” In the meantime, other early biotechs stayed in the private markets, biding their time and moving along their typical development paths. But biopharma has almost made up that gap, Perrone estimated, and today the industry has a “healthy” roster of later-stage companies that are properly positioned to go public. Indeed, there has been a notable uptick in megarounds in the back half of 2025, particularly for companies further on in clinical development—an indicator of market interest in mature science. Kailera’s $600 million series B in October, for example, was anchored by its Phase III-ready obesity program, while Tubulis’ $361 million raise that same month will help wrap up mid-stage testing for its antibody-drug conjugate. There have been 11 biotech IPOs this year so far, most recently Evommune’s November IPO with gross proceeds of $172.5 million . “The broader IPO market opened up in 2H25, and while it took a pause during the recent government shutdown, expectations are that the balance of 4Q25 and early-2026 will see healthy broader market new issuance,” Perrone said. Below, BioSpace chronicles five companies that went public during the pandemic gold rush. Verve Therapeutics IPO Date: June 2021 Proceeds: $306.7 million Arguably the most successful company on this list is Verve Therapeutics, which went public in June 2021 , raising nearly $307 million. Verve entered the industry with a mission to harness gene and base editing for cardiovascular diseases. While the Massachusetts-based biotech no doubt benefited from the pandemic-induced influx of money, it remained true to its identity, even as many peers pivoted to addressing the virus. In the months leading up to the IPO, Verve worked on its editing technology for lowering LDL cholesterol and a preclinical program for atherosclerotic cardiovascular disease (ASCVD). Eli Lilly took notice in June 2023, paying $60 million upfront to partner on what would eventually become Verve’s lead asset VERVE-102. Designed to be a one-time therapy, VERVE-102 is a base editor that disables the PCSK9 gene in the liver to reduce LDL-C levels. These days, VERVE-102 is in Phase Ib development for heterozygous familial hypercholesterolemia and ASCVD. A readout in April this year showed that the lowest dose of the therapy lowered LDL-C by 21% on average , while the highest dose hit 53% reduction. Impressed by VERVE-102’s potential, Lilly went all in on Verve in June, acquiring the biotech for up to $1.3 billion—a 113% premium to the company’s average closing price at the time. The takeover “signals confidence in Verve’s approach and provides global clinical and commercial capabilities,” Rajesh Sharma, associate director of Forecasting and Analytics at DelveInsight, told BioSpace in an email. Alongside VERVE-102, the pharma will also get Verve’s other clinical asset, VERVE-201, which targets the ANGPTL3 gene to treat homozygous familial hypercholesterolemia and refractory hypercholesterolemia. “Verve has largely delivered on its IPO promise in terms of science and platform execution,” Sharma said. “Verve demonstrates one of the most successful trajectories from the 2021 IPO wave.” Mergers & acquisitions Lilly Validates Gene Editing Space With $1.3B Verve Buy, But Analysts Are Skeptical The pending deal was rumored overnight after a report from the Financial Times , spurring analysts to speculate that if true, the entire gene editing space would see a boost at the markets. June 17, 2025 · 3 min read · Annalee Armstrong Caribou Biosciences IPO Date: July 2021 Proceeds: $304 million California’s Caribou Biosciences made a lot of money in 2021. In March of that year, the biotech brought in $115 million in series C proceeds for its pipeline of CAR T therapies and next-generation CRISPR platform. Then in July, Caribou announced its Nasdaq run and debuted on the public stock market after raising $304 million . Much of the excitement surrounding Caribou was driven by the big names attached to the biotech. Caribou was co-founded by CRISPR trailblazer Jennifer Doudna, who in October 2020 won the Nobel Prize in chemistry. Then, in February 2021, pharma powerhouse AbbVie fronted $40 million to leverage the biotech’s genome editing platform and advance two next-generation CAR T therapies. AbbVie, which participated as a new backer in Caribou’s series C, also promised up to $300 million in development, regulatory and launch milestones, plus global tiered royalties. But the years since have been challenging for Caribou. In September 2023, AbbVie turned its back on the CAR T specialist, citing strategic reasons. Less than a year later, in July 2024, Caribou was searching for ways to push its runway into the second half of 2026 and settled on a 12% workforce reduction as well as the discontinuation of all preclinical work related to its CAR natural killer (NK) cell programs. Caribou also pivoted from oncology to autoimmune diseases in September 2024, after its lead asset CB-010 won the FDA’s fast track designation for systemic lupus erythematosus. But immunology would not work out for Caribou either, forcing the biotech in April this year to return to its oncology origins —and lay off 32% in the process. As of June 30, 2025, Caribou had $183.9 million in cash, equivalents and marketable securities, enough to keep going into the second half of 2027. Layoffs Caribou Changes Course Again, Lays Off 32% of Workforce The cell and gene therapy company is cutting 47 employees and its entire lupus program to focus resources on two CAR Ts. The move follows a reconfiguration last year to move into immunology. April 25, 2025 · 1 min read · Dan Samorodnitsky Amylyx IPO Date: January 2022 Proceeds: $190 million Although Amylyx didn’t go public until early 2022 , the company first announced plans late in the golden year of 2021. At the time, everyone had their eyes on its amyotrophic lateral sclerosis (ALS) therapy AMX0035, an application for which the FDA had just accepted and granted priority review. The Massachusetts biotech grossed around $190 million from its IPO. In September that year—after initially narrowly losing and then winning an advisory committee vote—AMX0035 won the regulator’s approval for ALS and entered the U.S. market as Relyvrio. The drug was cleared under the FDA’s accelerated pathway, meaning that it needed to succeed in a Phase III confirmatory study to validate its clinical benefit. This study, dubbed PHOENIX, enrolled more than 660 patients and compared Relyvrio against placebo in improving disease severity. PHOENIX failed in March 2024. One month later, Amylyx withdrew Relyvrio from the market. Joe Thorne, analyst at TD Cowen, called this turn of events “disappointing” in an email to BioSpace , nevertheless saying that Amylyx has since “reinvented itself.” Indeed, in July 2024, just months after losing its only marketed product, Amylyx pivoted to the metabolic disease space and picked up a GLP-1 receptor antagonist—not an agonist like Novo Nordisk’s blockbuster drug semaglutide—from Eiger BioPharmaceuticals for $35 million . The drug, now called avexitide, is being tested for post-bariatric hypoglycemia, a common complication that arises in patients who have undergone bariatric surgery. A Phase III study in this indication is set to complete enrollment early next year with a topline readout expected in the third quarter of 2026. Avexitide is also in mid-stage development for congenital hyperinsulinism. “The main driver of value currently is not the same as” what it was at the time of Its IPO, Thome continued, noting that avexitide is now “the main focus for the company and investors.” Deals Amylyx Rebuilds Momentum Following Relyvrio Market Withdrawal While supportive of Amylyx’s acquisition of a GLP-1 drug, analysts say the company’s future hinges on key upcoming readouts from multiple products in its pipeline. July 24, 2024 · 5 min read · Heather McKenzie Invivyd IPO Date: August 2021 Proceeds: $355.8 million Of all the companies on this list, Invivyd most directly benefited from the influx of pandemic cash, with its $336 million series C in April 2021 promising to fund the development of ADG20, the biotech’s lead candidate being tested for the prevention and treatment of COVID-19. In August that year, the company set its sights on the public stock market, eventually raising $355.8 million —the largest IPO haul on this list—likewise largely to bankroll ADG20’s clinical studies, as well as lay the foundation for its manufacturing and commercialization. “The company went public during the pandemic with high expectations around broadly neutralizing COVID-19 antibodies,” Sneha Sharma, lead associate at DelveInsight told BioSpace , but these expectations “were challenged almost immediately.” In December 2021, in vitro data indicated that ADG20 was 300-fold weaker against the COVID-19 Omicron variant, which at the time was the emerging strain of concern. The readout wiped about 80% of Invivyd’s market value off the mapand would spawn a class action lawsuit against the biotech in 2023. In April 2022, Invivyd decided to hold off on filing an emergency use application for ADG20. Soon after rebranding to Invivyd in September 2022 , the biotech pivoted its pipeline to VYD222, another COVID-19 monoclonal antibody. This asset fared better, with a Phase III readout in December 2023 showing high serum titers of neutralizing antibodies in immunocompromised patients. The FDA granted the drug, branded Pemgarda, emergency use authorization for the pre-exposure prophylaxis of COVID-19 in March 2024. Invivyd has yet to secure full approval for Pemgarda. Invivyd has since remade itself into a post-pandemic player in the antiviral market, Sharma said, pointing to its next-generation antibody, called VYD2311, designed to neutralize post-Omicron COVID-19 variants. The company in September last year launched a Phase I study for the drug. Invivyd has also recently announced a $125 million public offering , which Sharma said “has significantly strengthened the balance sheet.” Still, “the commercial runway for COVID antibodies remains structurally limited”—and this will inevitably impact the biotech, she added. Invivyd’s long-term success will depend on a “pivot to broader respiratory threats like RSV and measles,” Sharma said. COVID-19 FDA Shoots Down Invivyd’s Bid to Expand EUA for COVID-19 Antibody Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent requirements for antibody activity boxed out its potential use as a post-exposure treatment. February 24, 2025 · 1 min read · Dan Samorodnitsky Metagenomi IPO Date: February 2024 Proceeds: $93.8 million Capping off this list is an outlier. While all other companies here went public during the peak of the pandemic boom, Metagenomi caught the tail end of the IPO rush. The California biotech launched its Nasdaq bid in early 2024, winning just under $94 million in proceeds. Shortly after, the IPO window snapped shut. “Metagenomi was one of the companies that went public with a pre-clinical pipeline,” TD Cowen’s Thome told BioSpace in an email. It did so on the basis of its “exciting” gene editing platform, he added, which caught the attention of some of the industry’s biggest names. In late 2020, Bayer led the biotech’s $65 million series A round, while Moderna in 2021 partnered with the startup to advance in vivo therapies for genetic diseases. Both Bayer and Moderna then co-led Metagenomi’s series B round in 2023, bringing in $275 million for the biotech. But the public markets have been hard on Metagenomi, which still does not have a candidate in the clinic. The company’s stock has fallen some 85% since its February 2024 debut. The company’s shares were trading at $1.60 apiece as of Dec. 2, nearly one-tenth of its $15-per-share IPO price. Despite this steep drop in value, Thome still believes that Metagenomi “has delivered on what it set out to do at the time of the IPO,” which is to advance a genome editing toolbox that can be used to develop curative therapies. “Investors knew that they had to wait for clinical validation of the gene editing technology,” Thome said. Metagenomi is making progress, according to Thome, with the goal of entering the clinic next year. Last month, the biotech laid off 25% of its workforce and replaced its CEO—a strategic restructuring initiative that would provide more resources to drive the hemophilia A candidate MGX-001 forward and extend its cash runway into the fourth quarter of 2027. This move, Thome added, will help Metagenomi to “prioritize cash and focus on the most promising programs,” and give the company more leeway “to bring those programs to an inflection point.” At the end of the third quarter, Metagenomi had $184.1 million in cash, equivalents and marketable securities. Layoffs Metagenomi Chops 25% of Workforce, CEO To Advance Hemophilia A Program The strategic initiative will extend Metagenomi’s cash runway into the fourth quarter of 2027. That same year, the company expects to generate initial Phase I data for its lead asset MGX-001 in hemophilia A. November 12, 2025 · 2 min read · Tristan Manalac

｜中肽生化内容团队编辑 在经历了跌宕起伏的2025年后，多肽药物开发在2026年又将迎来一批后期临床的“到彼岸”。本文选取在clinicaltrials.gov上注册，在中国或美国进行的3，4期多肽药物的临床试验，它们将于2026年实现主要终点的完成。所涉适应症涵盖遗传性生长障碍、代谢与肥胖相关疾病、肿瘤辅助或免疫治疗、内分泌功能紊乱、炎症与自身免疫疾病，以及分子影像诊断等多个彼此独立的临床场景。 多肽药物：Vosoritide 开发商：BioMarin 适应症：Hypochondroplasia (轻型软骨发育不全) 临床：NCT06455059 ，（CANOPY-HCH-3 ）3期 Primary Completion: 2026-08-01 这项 III 期临床研究（NCT06455059）聚焦于轻型软骨发育不全（Hypochondroplasia）这一由 FGFR3 激活突变驱动的遗传性骨骼发育障碍，评估 Vosoritide 作为疾病干预手段的疗效与安全性。Vosoritide 是一种 C 型利钠肽（CNP）类似物，通过激活 NPR-B（NPR2）–cGMP 信号通路，在生长板软骨细胞中功能性对冲 FGFR3 过度信号，从而改善内软骨成骨过程；这一机制已在同一通路相关的骨骼发育障碍中建立了明确的生物学合理性。此前的 II 期研究显示，在经基因检测确诊的 HCH 儿童中，vosoritide 治疗可带来相较基线具有一致方向性的年化生长速度（AGV）改善，且整体安全性特征与其既往在 FGFR3 相关疾病中的经验相符，为进入确证性研究奠定了基础。在此背景下，CANOPY-HCH-3 采用随机、分层、安慰剂对照、双盲、多中心设计，对从既往研究滚入的儿童患者进行 52 周每日皮下注射治疗，以 AGV 作为主要终点，系统验证该机制导向的多肽治疗能否在 HCH 人群中转化为稳定、可重复的临床获益。研究由 BioMarin Pharmaceutical赞助，代表其在 FGFR3 相关罕见骨骼发育障碍领域对既有平台的进一步拓展。 多肽药物： GLSI-100（GP2 + GM-CSF） 开发商： Greenwich LifeSciences, Inc. 适应症： HER2/Neu 阳性乳腺癌（高复发风险、完成新辅助及辅助治疗后人群） 临床阶段： III 期（FLAMINGO-01，NCT05232916） Primary Completion： 2026-12 这项 III 期临床研究（FLAMINGO-01，NCT05232916）评估 GLSI-100 在 HER2/Neu 阳性乳腺癌高复发风险人群中的疗效与安全性。GLSI-100 是一种多肽肿瘤疫苗型免疫治疗，由 HER2/Neu 衍生肽 GP2 联合 GM-CSF 佐剂构成，其靶点为 HER2 蛋白跨膜区表位，设计目标是在完成新辅助治疗及术后辅助曲妥珠单抗为基础标准治疗后，通过诱导HER2 特异性 CD8⁺ T 细胞免疫反应，降低残余病灶或高复发风险患者的复发概率。既往 II 期研究在 HLA-A*02 阳性、HER2 阳性乳腺癌患者中显示，GLSI-100 可诱导持久的抗原特异性免疫应答，并在部分亚组中观察到无病生存期（DFS）改善趋势，且安全性良好，主要不良反应为注射部位反应和轻度全身免疫相关症状。在此基础上，FLAMINGO-01 采用前瞻性、随机、双盲、安慰剂对照、多中心设计，计划入组约 750 例 HER2 阳性受试者，主要研究人群为 HLA-A*02 阳性患者，同时设置第三个开放标签队列探索非 HLA-A*02 阳性人群的免疫治疗潜力。研究旨在系统验证该 HER2 靶向多肽疫苗策略是否能够在高复发风险人群中转化为具有临床意义的长期结局改善。 多肽药物： PJ009 开发商： Chongqing Peg-Bio Biopharm Co., Ltd.（重庆派金生物科技） 适应症： Short Bowel Syndrome（短肠综合征）； 临床阶段： III 期（NCT06512584，CQPJ-PJ009-III） Primary Completion： 2026-03-30 这项 III 期临床研究（NCT06512584）评估 PJ009 在短肠综合征（Short Bowel Syndrome，SBS）且需长期肠外营养支持患者中的疗效与安全性。治疗方案为按体重每日皮下注射，核心评估围绕肠外营养依赖程度的变化及整体安全性展开，验证 PJ009 是否能够在 SBS 人群中带来具有临床意义的营养支持负担改善。 多肽药物： 68Ga-PSMA-11 开发商： Telix Pharmaceuticals (Innovations) Pty Limited 适应症：前列腺癌（Prostate Cancer，影像学检测） 临床阶段： III 期（NCT07052214） Primary Completion： 2026-06 这项 III 期研究评估 68Ga-PSMA-11 PSMA PET 联合 MRI (磁共振成像) 相较标准诊疗路径在前列腺癌检测中的诊断价值。研究以 PSMA 靶向多肽放射性配体成像为核心，通过与 MRI 结果联合指导系统性及靶向活检，旨在提高临床显著性前列腺癌的检出率并减少不必要的活检。 多肽药物： Avexitide 开发商： Amylyx Pharmaceuticals Inc. 适应症： Post-Bariatric Hypoglycemia（术后低血糖，Roux-en-Y 胃旁路术后） 临床阶段： III 期（NCT06747468，LUCIDITY / AVX-001） Primary Completion： 2026-03 这项 III 期临床研究（LUCIDITY，NCT06747468）评估 Avexitide 在减重手术后低血糖（Post-Bariatric Hypoglycemia，PBH）患者中的疗效与安全性。PBH 常见于 Roux-en-Y 胃旁路术（RYGB）后，其核心病理与术后 GLP-1 信号异常增强、继发高胰岛素反应密切相关。Avexitide 为一款 GLP-1 受体拮抗多肽，通过抑制过度的 GLP-1 介导信号，减少餐后胰岛素峰值，从而降低低血糖事件发生频率。该研究由 Amylyx Pharmaceuticals Inc. 赞助，验证这一机制导向的多肽拮抗策略是否能够为 PBH 提供稳定、可长期使用的药物治疗方案。 多肽药物： iGlarLixi（insulin glargine + lixisenatide） 开发商： Sanofi 适应症： 2 型糖尿病（T2D，口服降糖药控制不佳的中国初治胰岛素人群） 临床阶段： IV 期（NCT06671587，China Soli-CGM / LPS18034） Primary Completion： 2026-09-18 这项 IV 期、多中心、随机、开放标签研究（China Soli-CGM，NCT06671587）比较 iGlarLixi 与胰岛素甘精 U100（Gla-100）在中国口服降糖药治疗失败的 2 型糖尿病患者中的血糖控制效果。研究以连续血糖监测（CGM）测得的血糖达标时间（TIR）变化为主要终点，评估在真实世界治疗路径中，将基础胰岛素与 GLP-1 受体激动剂（lixisenatide）组合是否能够在不增加治疗复杂度的前提下，带来更优的整体血糖稳定性。研究结果将为固定复方注射制剂在中国 T2D 人群中的临床定位与使用策略提供循证依据。 多肽药物： CagriSema（cagrilintide + semaglutide） 开发商： Novo Nordisk A/S 适应症： 2 型糖尿病（T2D，已使用二甲双胍和/或 SGLT2 抑制剂但控制不佳） 临床阶段： III 期（NCT06534411，REIMAGINE 5） Primary Completion： 2026-06-02 这项 III 期随机对照研究（REIMAGINE 5）比较 CagriSema 与 Tirzepatide 在 2 型糖尿病患者中的降糖与减重效果。CagriSema 为 cagrilintide（胰淀素类似物）与 semaglutide（GLP-1 受体激动剂）的联合给药方案，研究采用每周一次皮下注射，评估其在标准口服降糖治疗基础上的血糖控制和体重改善潜力。该研究计划定位于与双/多靶点肠促胰素类药物的头对头比较，为 CagriSema 在 T2D 治疗中的临床价值提供直接对照证据。 多肽药物： CagriSema（cagrilintide + semaglutide） 开发商： Novo Nordisk A/S 适应症： 2 型糖尿病（T2D，二甲双胍治疗后控制不佳，可合并或不合并 SGLT2 抑制剂） 临床阶段： III 期（NCT06221969） Primary Completion： 2026-02-20 这项 III 期随机对照研究（NCT06221969）比较 CagriSema（cagrilintide + semaglutide，2.4 mg/2.4 mg，每周一次皮下注射）与 Tirzepatide（15 mg，每周一次）在 2 型糖尿病患者中的降糖与减重效果。研究入组约 1,000 例在二甲双胍基础治疗下血糖控制不佳的患者，允许合并或不合并 SGLT2 抑制剂，核心在于通过胰淀素通路（cagrilintide）与 GLP-1 通路（semaglutide）的联合调控，评估其相较多靶点肠促胰素药物的临床获益幅度，为 CagriSema 在 T2D 治疗中的定位提供直接头对头证据。 多肽药物： Tirzepatide 开发商： Eli Lilly 适应症： 2 型糖尿病（T2D，斋月禁食期间用药管理） 临床阶段： IV 期（NCT06635057） Primary Completion： 2026-04 这项 IV 期、多中心、多国家、开放标签、单臂研究（T-RAM，NCT06635057）评估 Tirzepatide 在斋月禁食背景下启动并按说明书用药的有效性与安全性。研究关注在禁食—进食节律显著改变的情境中，每周一次给药的 GLP-1/GIP 双受体激动多肽是否能够维持稳定的血糖控制并避免低血糖风险，为穆斯林 T2D 人群在斋月期间的真实世界用药策略提供循证依据。 多肽药物： Tirzepatide 开发商： Eli Lilly 适应症：青少年肥胖或超重（伴至少一种体重相关合并症） 临床阶段： III 期（NCT06075667） Primary Completion： 2026-05 这项 III 期随机、双盲、安慰剂对照研究（NCT06075667）评估 Tirzepatide 在青少年肥胖或超重合并症人群中的疗效、安全性与药代动力学。研究采用每周一次给药方案，在生活方式干预基础上比较其相较安慰剂的体重改善效果，并设置长期延伸治疗以评估持续用药的安全性与维持效应，为 GLP-1/GIP 双受体激动多肽在青少年体重管理中的临床应用提供确证性证据。 多肽药物： Tirzepatide 开发商： Eli Lilly 适应症：肥胖或超重（伴体重相关合并症，体重减轻后的维持治疗） 临床阶段： III 期（Phase 3b）（NCT06047548） Primary Completion： 2026-05 这项 III 期（Phase 3b）随机对照研究（SURMOUNT-MAINTAIN，NCT06047548）评估 Tirzepatide 在完成初始体重下降后的体重维持阶段的疗效与安全性。研究设计为先进行 60 周开放标签减重期，在达到随机条件后进入 52 周双盲维持期，比较固定低剂量（5 mg）或最大耐受剂量（MTD）的 tirzepatide 与安慰剂在维持既有体重减轻效果方面的差异。该研究重点回答 GLP-1/GIP 双受体激动多肽是否能够在长期治疗中稳定维持减重获益，为肥胖的慢病化、长期管理策略提供循证依据。 多肽药物： Retatrutide 开发商： Eli Lilly 适应症：肥胖症 临床阶段： III 期（NCT06662383） Primary Completion： 2026-12 这项 III 期随机、双盲研究（NCT06662383）头对头比较 Retatrutide 与 Tirzepatide 在成人肥胖人群中的疗效与安全性。Retatrutide 为 GLP-1/GIP/胰高血糖素三受体激动多肽，在 GLP-1/GIP 双通路基础上引入胰高血糖素通路调控，旨在进一步增强能量消耗与体重下降幅度；Tirzepatide 则作为已建立临床基准的 GLP-1/GIP 双受体激动多肽作为直接对照。研究计划入组约 800 例受试者，治疗随访约 89 周，定位于评估三重肠促胰素策略是否能够在肥胖治疗中实现相较现有双靶点方案的增量获益。 多肽药物： Inpegsomatropin 开发商： Xiamen Amoytop Biotech Co., Ltd. 适应症：特发性矮小（Idiopathic Short Stature，ISS） 临床阶段： III 期（NCT06927310，PEGPESEN-4-2-001） Primary Completion： 2026-03 这项 III 期、多中心、随机、开放标签、阳性对照研究（NCT06927310）比较 Inpegsomatropin 与重组人生长激素（rhGH）在特发性矮小（ISS）儿童中的疗效与安全性。Inpegsomatropin为经 PEG 修饰的人生长激素多肽，采用每周一次皮下注射给药方案，研究以 52 周治疗期为核心，评估其在促进线性生长方面是否能够达到或接近每日给药 rhGH 的疗效，同时验证长效给药在依从性与长期安全性方面的潜在优势。 多肽药物： JNJ-77242113 (Icotrokinra) 开发商：J&J 适应症：中重度斑块型银屑病（Plaque Psoriasis） 临床阶段： III 期（NCT06934226，ICONIC-ASCEND） Primary Completion： 2026-03-30 这项 III 期、多中心、随机、双盲研究（ICONIC-ASCEND，NCT06934226）比较 JNJ-77242113 (Icotrokinra) 与安慰剂及 Ustekinumab 在中重度斑块型银屑病患者中的疗效与安全性。JNJ-77242113 是一款口服 IL-23 受体拮抗多肽，通过阻断 IL-23/IL-23R 通路抑制 Th17 相关炎症反应；Ustekinumab 作为 IL-12/IL-23 单抗提供成熟生物制剂对照。研究旨在验证口服多肽直接拮抗受体的策略，是否能够在保持生物学疗效的同时，提供不同于注射抗体的给药便利性与长期管理潜力。 多肽药物： Cyclosporine（眼用凝胶） 赞助商： Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. 适应症：中至重度干眼病（Dry Eye Disease） 临床阶段： III 期（NCT06766357） Primary Completion： 2026-02 这项 III 期、多中心、随机、双盲、载体对照研究（NCT06766357）评估环孢素（Cyclosporine）眼用凝胶在中至重度干眼病患者中的疗效与安全性。Cyclosporine 是一款环状十一肽免疫抑制剂，通过抑制钙调神经磷酸酶（calcineurin），下调 T 细胞介导的炎症反应，从而改善干眼相关的炎症病理。研究以 84 天双盲治疗期作为主要疗效分析阶段，随后进入开放用药的安全性观察期，旨在验证局部多肽免疫调节策略在中重度干眼治疗中的临床价值与耐受性。