Delving into the Latest Updates on Ribupatide with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

利鲁帕肽, 瑞波肽, HRS 9531

+ [5]

Target

GIPR x GLP-1R

Action

agonists

Mechanism

GIPR agonists(Gastric inhibitory polypeptide receptor agonists), GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic DiseaseNervous System DiseasesRespiratory Diseases+ [5]

Active Indication

ObesityAtherosclerosisSleep Apnea, Obstructive+ [7]

Inactive Indication-

Originator Organization

Fujian Suncadia Pharmaceuticals Co Ltd.

Active Organization

Kailera Therapeutics, Inc.

Fujian Suncadia Pharmaceuticals Co Ltd.

Inactive Organization-

License Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Kailera Therapeutics, Inc.

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 939740479

Source: *****

WALTHAM, Mass., May 28, 2026 (GLOBE NEWSWIRE) -- Kailera Therapeutics, Inc. (Nasdaq: KLRA), a clinical-stage biotechnology company focused on elevating the next era of obesity care, today announced that Ron Renaud, President and Chief Executive Officer, will present at the 2026 Jefferies Global Healthcare Conference on Thursday, June 4, at 10:30 am EDT. A live webcast will be available on the Events page of Kailera’s investor website. A replay of the conference webcast will be archived on the company's website for 90 days. About Kailera Therapeutics Kailera Therapeutics (Kailera) is a clinical-stage biotechnology company focused on elevating the next era of obesity care by progressing a diversified pipeline to provide options for people living with obesity no matter where they are in their treatment journey. With an obesity-first focus, Kailera is advancing four clinical-stage product candidates leveraging multiple GLP-1-based mechanisms of action and routes of administration specifically designed to address critical needs in the current therapeutic landscape with a lead product candidate, ribupatide injection (also known as KAI-9531), that has the potential for the greatest weight loss. Ribupatide injection is in global Phase 3 trials as a once-weekly injectable GLP-1/GIP receptor dual agonist. Kailera is expanding the ribupatide franchise by developing a once-daily oral formulation with the goal of providing an oral option with the potential for compelling weight loss and highly differentiated tolerability. Additionally, Kailera is advancing the development of KAI-7535, a once-daily oral small molecule GLP-1 receptor agonist, and KAI-4729, a once-weekly injectable GLP-1/GIP/glucagon receptor tri-agonist. Kailera’s vision is to deliver category-leading obesity management medications that give people the power to restore their health and transform their lives. Kailera is based in Waltham, MA. For more information, visit and follow us on LinkedIn and X . Special Note Regarding Kailera Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the pro product candidates, the potential of Kailera’s portfolio, the timing, design and outcome of research and development activities, market opportunities for product candidates, the competitive landscape, and participation in upcoming events or presentations. Forward-looking statements can be identified by terms such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," “suggest,” "plan," “goal,” “vision,” "potential," "predict," "project," "should," "target," "will," "would," or similar expressions and the negatives of those terms. Kailera cannot assure you that the forward-looking statements in this press release will prove to be accurate. Information in this press release may also include statements relating to past performance, which should not be regarded as a reliable indicator of future performance. Forward-looking statements are based on current expectations and assumptions together with projections of the future which are inherently uncertain, and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, uncertainties inherent in clinical development, regulatory review, manufacturing, competition, market opportunities, reliance on third parties, estimates of capital requirements, needs for additional financing, and other important factors, including those discussed under the caption “Risk Factors” in Kailera’s filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release, and Kailera undertakes no obligation to update or revise any forward-looking statements. Kailera may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. Contact Information Maura Gavaghan Vice President, Corporate Communications and Investor Relations maura.gavaghan@kailera.com

27 May 2026

·www.biospace.com

Kailera walks path paved by Lilly in post-IPO ‘catalyst-rich period’

iStock, Yutthana Gaetgeaw Kailera Therapeutics is advancing a pipeline of weight loss medicines that mirror that of Eli Lilly’s: an injectable GLP-1/GIP dual agonist like Zepbound, an oral GLP-1 like Foundayo and a triple-G therapy like retatrutide. After a record-breaking $625 million IPO , Kailera Therapeutics will tread a relatively safe road as the biotech’s trifecta of obesity drugs follow in the footsteps of one of the industry’s leading weight-loss players. “We view Kailera’s broad GLP-1-based pipeline as largely de-risked through clinical and commercial validation from competitor programs, especially those from Eli Lilly,” William Blair told investors in a Wednesday note. Kailera’s lead asset is ribupatide, a dual agonist of the GLP-1 and GIP receptors, much like Lilly’s mega-blockbuster Zepbound. Kailera is also advancing a small-molecule GLP-1 pill called KAI-7535 and a “triple-G” agonist dubbed KAI-4729—assets that work similarly to Lilly’s recently approved Foundayo and investigational retatrutide, respectively. Despite the high bar that Lilly has set in the obesity market, there remains a place for Kailera, William Blair contended, noting that the company’s medicines could provide “options for patients with various weight-loss goals and across the full treatment journey.” Kailera made a huge splash last month when it went public with a $625 million raise —the largest biotech IPO haul in history, topping Moderna’s $600 million from late 2018. Kailera launched in October 2024 with $400 million in starting capital and ex-China rights to a clutch of weight-loss assets from China’s Jiangsu Hengrui. Before going public, the biotech in October 2025 brought in $600 million in series B proceeds. IPO The 5 largest IPOs in biopharma history With an IPO raise of $625 million, Kailera Therapeutics now holds the new record for the largest public market debut. April 22, 2026 · 9 min read · Tristan Manalac Read more Now trading on the Nasdaq, Kailera is “heading into a catalyst-rich period” with clinical updates on the horizon for all of its obesity programs, according to William Blair. On Wednesday, for instance, the biotech announced the initiation of a Phase 2b study testing higher doses of injectable ribupatide, with data expected next year. Ribupatide is also entering a broad Phase 3 weight-loss program called KaiNETIC. Initial findings are slated for 2028. Kailera on Wednesday also provided data for its weight-loss pill KAI-7535 from a Phase 3 diabetes study conducted by Chinese partner Hengrui. At 32 weeks, patients taking the drug saw a 1.40% to 1.68% decrease in HbA1c levels, a measure of blood average sugar concentrations over the last two to three months. Placebo comparators saw a 0.06% drop in HbA1c. Hengrui will report Phase 3 data for KAI-7535 in obesity later this year, Kailera said. As for the triple-G drug, the biotech reported a mean weight reduction of 16% at 12 weeks, as compared with 5.4% in placebo counterparts, based on data from a Phase 1 study conducted in China. Kailera plans to initiate an early-stage program for KAI-4729 outside China, with data expected next year—where it will face high expectations set by Lilly’s retatrutide. The Big Pharma’s asset earlier this month elicited 28.3% weight reduction over 80 weeks. “We anticipate 2027 to be a catalyst-rich year” for Kailera, William Blair analysts told investors on Wednesday, adding that the biotech is “positioned to be a strong contender in the obesity market.” IPO UPDATE: Kailera breaks biotech IPO record with $625M debut Obesity-focused Kailera Therapeutics debuted on the Nasdaq Friday after raising a record $625 million, beating Moderna’s $600 million from 2018. April 17, 2026 · 4 min read · Tristan Manalac Read more

Clinical ResultPhase 1Phase 2Phase 3IPO

26 May 2026

·www.biopharmadive.com

Kailera’s three-pronged obesity shot shows promise in early trial

Dive Brief:Kailera said Wednesday its triple-acting obesity shot spurred double-digit weight loss in a short Phase 1 dosing trial conducted in China by partner Hengrui Pharmaceuticals, with investigators reporting that enrollees lost up to 16% of their body weight over 12 weeks.The data compare favorably to early-stage data reported by Zepbound maker Eli Lilly with its so-called triple-G agonist drug, which hadnt reached 10% at the 12-week time point, wrote T.D. Cowen analyst Yaron Werber. Kailera is readying its own Phase 1 trial outside China, which will have data in 2027, while Hengrui is advancing the drug into Phase 2 in China.Data from the triple-G drug, called KAI-4729, follows positive mid-stage data for Kailera and Hengruis dual-acting Zepbound competitor, which has already entered a Phase 3 study. The rapid advancement of Kaileras pipeline licensed from Hengruihas driven investor enthusiasm for the company and allowed it to enter the publicly traded markets with one of biotechs largest-ever initial public offerings.Dive Insight:Kailera is one of dozens of companies developing obesity drugs in the hope that they can crack through Lilly and Novo Nordisks formidable franchises fortified by the incretin stimulating drugs Zepbound, Wegovy and Foundayo. Those who succeed could grab a share of a market that some analysts estimate will exceed $100 billion a year.Supported by its $625 million IPO, a haul that will fund it through 2028, Kailera is one of the most closely watched. It chose to take advantage of Chinas less-restrictiveregulatory structure for drug discovery by in-licensing four assets from Hengrui, which include the lead drug ribupatide. The four drugs have a backbone of a GLP-1 stimulating drug, the main channel of Novos drug Wegovy, and ribupatide adds GIP to the mix, similar to Zepbound.Along with GLP-1 and GIP, KAI-4729 simulates another gut hormone called glucagon, similar to Lillys retatrutide, the most-advanced triple-G drug. In a Phase 3 trial, retatrutide helped people with obesity lose up to 28% of their body weight when taken over 80 weeks.The data for KAI-4729 came from a Phase 1 trial that tested steadily increasing doses to evaluate side effects as well as determine the best one to advance into pivotal trials. In a group of 12 enrollees who started at a 2 milligram weekly dose and escalated to 12 milligrams by 12 weeks, the weight loss was 16%, Kailera said.The trial included ribupatide as an active control as well as a placebo. People who got the placebo lost 5% of their body weight, a high rate compared to most trials of obesity drugs.Kailera said the drug demonstrated favorable safety and tolerability data consistent with GLP-1-based treatments, with mild to moderate gastrointestinal side effects.This result is a highly encouraging early signal and consistent with the preclinical thesis that 4729 is a step up in potency vs retatrutide, wrote Werber in a note to clients. '

Phase 1Clinical ResultPhase 3IPOPhase 2

100 Deals associated with Ribupatide

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	NDA/BLA	China	Fujian Suncadia Pharmaceuticals Co Ltd.	02 Sep 2025
Atherosclerosis	Phase 3	China	Fujian Suncadia Pharmaceuticals Co Ltd.	29 May 2026
Sleep Apnea, Obstructive	Phase 3	China	Fujian Suncadia Pharmaceuticals Co Ltd.	10 Jul 2025
Diabetes Mellitus, Type 2	Phase 3	China	Fujian Suncadia Pharmaceuticals Co Ltd.	31 Oct 2024
Polycystic Ovary Syndrome	Phase 2	-	Fujian Suncadia Pharmaceuticals Co Ltd.	01 Sep 2024
Chronic heart failure	Phase 2	China	Fujian Suncadia Pharmaceuticals Co Ltd.	06 May 2024
Heart failure with normal ejection fraction	Phase 2	China	Fujian Suncadia Pharmaceuticals Co Ltd.	06 May 2024
Chronic Kidney Diseases	IND Approval	China	Fujian Suncadia Pharmaceuticals Co Ltd.	12 Feb 2026
Metabolic Dysfunction Associated Steatohepatitis	IND Approval	China	Fujian Suncadia Pharmaceuticals Co Ltd.	02 Dec 2025
Obesity Hypoventilation Syndrome	IND Approval	China	Fujian Suncadia Pharmaceuticals Co Ltd.	11 Apr 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06396429 (HRS9531-301, NEWS) Manual	Phase 3	Overweight \| Obesity	567	HRS9531注射液 2 mg、4 mg、6 mg	uwokkjvmen(walubwnmzz) = aiekozlryo utditonpde (wotukjjxlo ) View more	Positive	16 Jul 2025
				Placebo	uwokkjvmen(walubwnmzz) = tlezcteesy utditonpde (wotukjjxlo )
ADA 12025 \| ADA 22025	Phase 1	Obesity	249	HRS9531	jxogjqlyks \| rstnvqysyw(zqenajnxfl) = waxmdebrut ebyufniagt (dgiogzhpsk ) View more	Positive	20 Jun 2025
				Placebo	jxogjqlyks \| rstnvqysyw(zqenajnxfl) = bjimceqxvf ebyufniagt (dgiogzhpsk ) View more
NCT06054698 (HRS9531-203, GlobeNewswire \| ADA2025 \| NEWS) Manual	Phase 2	Obesity	61	HRS9531 8 mgHRS9531 8 mg	gjphnsfzww(gsurdziqaa) = fqsdjapchw btjyxmbnwt (npwgwkcncp ) View more	Positive	13 Jan 2025
				Placebo	gjphnsfzww(gsurdziqaa) = cizwlandis btjyxmbnwt (npwgwkcncp ) View more
NCT05966272 (HRS9531-202, EASD2024) Manual	Phase 2	Diabetes Mellitus, Type 2	199	HRS9531 1.0 mg	mfhziorvvw(jyodzuztdt) = uvdhociksi rnghwyloue (cfwfavnwcg, -2.4 to -1.9)	Positive	09 Sep 2024
				HRS9531 2.0 mg	mfhziorvvw(jyodzuztdt) = ptwlhjglpk rnghwyloue (cfwfavnwcg, -2.8 to -2.3)
NCT05881837 (ADA2024) Manual	Phase 2	Obesity	249	HRS9531 1.0 mg	vqidrlxjuz(snqznexkxh) = sruqnhwdrp yojezititm (pkhpqyjlox, -7.3 to -3.5) View more	Positive	21 Jun 2024
				HRS9531 3.0 mg	vqidrlxjuz(snqznexkxh) = xrmcdccjyi yojezititm (pkhpqyjlox, -15.2 to -11.5) View more
NCT05516966 (IDF2023) Manual	Phase 1	Diabetes Mellitus, Type 2	63	HRS9531 0.3 mg	uehdpjnmgf(tyocorjgxp) = 84.1% (mostly mild) tsytviyufk (zevlrqyrqg )	Positive	04 Dec 2023
				HRS9531 1.5 mg
NCT05152277 (ADA 12023 \| ADA 22023) Manual	Phase 1	Diabetes Mellitus, Type 2	90	HRS9531 (SAD)	jwapasaous(eutdpzfixr) = The most common adverse events were abdominal distension and nausea in SAD, and urine ketone body present and nausea in MAD; all considered mild to moderate in severity (mostly mild). ppsnlfywca (iaibiqqkmo ) View more	Positive	20 Jun 2023
				HRS9531 (MAD)

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