Factbox-Weight-loss drug developers line up to tap lucrative market as competition heats up

Dec 23 (Reuters) - The weight-loss drug market is surging, with biotech firms racing to win share in a sector dominated by Novo Nordisk and Eli Lilly.

Analysts forecast the industry will generate about $150 billion in annual sales in the next decade.

Novo Nordisk won a key first-mover advantage after U.S. regulators approved a pill version of its blockbuster obesity injection Wegovy, the first GLP-1 pill cleared for obesity.

The following is a list of weight-loss drugs in development by Novo, Lilly and other companies chasing the next blockbuster treatment:

NOVO NORDISK

The Food and Drug Administration approved the oral version of Novo Nordisk’s injectable weight loss drug Wegovy, making it the first GLP-1 pill cleared for obesity.

The company is developing several experimental weight-loss drugs, a next-generation injection called amycretin, and another drug called CagriSema.

Amycretin showed statistically significant weight loss of up to 14.5% at 36 weeks in patients with type 2 diabetes in a mid-stage study.

Novo said the drug appeared safe and well tolerated, with mostly mild-to-moderate gastrointestinal side effects. Late-stage trials are planned for 2026.

Amycretin targets GLP-1 and amylin hormones.

Last year, a daily-pill version of amycretin produced 13.1% weight loss after 12 weeks in an early-stage trial.

The shot version of amycretin helped patients lose 22% of their weight in 36 weeks in an early-stage trial.

CagriSema, touted as a potent successor to Wegovy, produced weaker-than-expected data in two separate late-stage trials. The drug helped overweight patients cut their weight by 22.7% in one of the trials, below Novo's expectations of 25%.

Novo filed a marketing application for potential U.S. approval of CagriSema in December.

In addition to those two, Novo has struck licensing deals for drugs in earlier stages of testing, including a deal worth up to $2 billion with China-based United Laboratories for its "triple-G" weight-loss drug candidate that targets three hormones.

PFIZER

Under the terms of the Metsera buyout agreement, Pfizer would gain access to the biotech firm's obesity drugs, currently in early-to-mid-stage development, including MET-097i, a GLP-1 therapy designed for a once-monthly injection, compared with weekly treatments from Lilly and Novo.

Metsera is also developing MET-233i, a treatment that mimics the pancreatic hormone amylin.

In September, MET-097i demonstrated 14.1% average weight loss after 28 weeks in two mid-stage trials. Metsera plans to begin late-stage trials later this year and develop the drug for use in combination therapies and oral versions.

Pfizer had discontinued the development of two oral GLP-1 drug candidates - lotiglipron in 2023 and danuglipron in 2025 - due to liver safety concerns, leaving it without a viable in-house obesity drug.

Pfizer in December entered into an exclusive licensing agreement with YaoPharma, a subsidiary of China's Shanghai Fosun Pharmaceutical, to develop and commercialize an experimental weight-management treatment.

YaoPharma will receive an upfront payment of $150 million and could earn up to $1.94 billion in milestone payments.

ELI LILLY

Lilly is advancing its experimental once-weekly amylin-based obesity drug, eloralintide, into late-stage trials in December after it helped patients lose up to 20.1% of their weight in a mid-stage study.

In August, the drugmaker said its experimental weight-loss pill, orforglipron, helped overweight adults with type 2 diabetes lose 10.5% of their body weight at the highest 36 mg dose over 72 weeks in a late-stage trial.

Earlier this year, Lilly's orforglipron helped type 2 diabetes patients lose nearly 8% of their body weight over 40 weeks in a late-stage trial.

That compares favorably with Novo's injected drug Ozempic. Diabetic patients on the highest dose of Ozempic lost roughly 6% of their body weight.

Lilly expects to seek regulatory approvals for orforglipron by the end of the year.

In December, a late-stage trial showed that next-generation obesity drug candidate retatrutide helped patients lose an average of 28.7% of their weight, outperforming its blockbuster drug Zepbound and reinforcing the company's lead in the fast-growing market.

Lilly signed a deal with China-based biotech Laekna last year to develop an obesity drug that aims to help patients lose weight while preserving muscle.

In August, Lilly signed a deal worth up to $1.3 billion with Superluminal Medicines to discover and develop small-molecule drugs through AI to treat obesity and other cardiometabolic diseases.

ROCHE

In September, Roche said it would advance its experimental obesity drug, CT-388, acquired through its $2.7 billion purchase of Carmot Therapeutics in 2023, into a late-stage trial. Carmot's once-weekly injection belongs to the same class as Lilly's Zepbound.

In March, Roche acquired rights to Zealand Pharma's obesity treatment, petrelintide, in a deal potentially worth up to $5.3 billion.

Last year, the company announced that a second drug candidate from its Carmot purchase yielded positive results in an early-stage trial.

AMGEN

Last year, Amgen's closely watched experimental obesity drug MariTide helped overweight patients shed up to 20% of their body weight in a year-long mid-stage trial.

The company said it was expecting to have data before year-end from two key mid-stage MariTide studies.

Analysts said MariTide's weight-loss benefit was in line with Wegovy and Zepbound, but with slightly more side effects.

MERCK

Last year, Merck signed a licensing deal worth up to $2 billion for Chinese biotech Hansoh Pharma's experimental oral drug to treat obesity, becoming a late contender in the race to offer a weight-loss pill to replace weekly shots.

The drug, HS-10535, is a GLP-1 receptor agonist candidate similar to Wegovy and Zepbound.

ASTRAZENECA

AstraZeneca's experimental weight-loss pill, licensed a year ago from China's Eccogene for up to $2 billion, was found to be safe and tolerable in an early-stage trial in November 2024.

The drugmaker said it has progressed the once-daily pill, called AZD5004, into mid-stage trials.

VIKING THERAPEUTICS

In August, Viking Therapeutics said its oral weight-loss drug, VK2735, helped patients lose 12.2% of their body weight after 13 weeks in a mid-stage trial of 280 overweight adults, missing Wall Street's top-end expectations of 15%.

SCHOLAR ROCK

In June, Scholar Rock said its experimental drug, apitegromab, combined with Lilly's Zepbound, helped patients preserve significantly more lean mass in a mid-stage trial.

In Scholar Rock's study, patients who received a combination of tirzepatide - the active ingredient in Zepbound - and Scholar's apitegromab lost 3.4 pounds of lean mass after 24 weeks, compared with those on tirzepatide alone, who lost 7.6 pounds of lean mass.

ALTIMMUNE

Altimmune's experimental obesity drug, pemvidutide, helped reduce weight by 15.6% on average and showed continued weight loss at the end of treatment in a mid-stage trial in 2023.

Patients, however, also experienced nausea and vomiting of mild and moderate severity.

ZEALAND PHARMA

Danish biotech Zealand Pharma said last year a high dose of its weight-loss drug candidate petrelintide helped reduce weight by an average of 8.6% after 16 weekly doses in an early-stage study.

Zealand in March agreed to a $5.3 billion partnership with Roche to develop and commercialise its lead experimental obesity drug, petrelintide.

STRUCTURE THERAPEUTICS

Structure Therapeutics said on Monday that its experimental oral obesity pill showed a 11.3% reduction in weight at the 120 mg dose at 36 weeks in a mid-stage study.

Another mid-stage study exploring higher doses of aleniglipron showed weight loss of up to 15.3% at 36 weeks.

The company said the results support advancement to late-stage development, expected to initiate by mid-2026 following an FDA meeting in the first half of next year.

(Reporting by Sahil Pandey, Mariam Sunny, Siddhi Mahatole, Padmanabhan Ananthan, Kamal Choudhury, Pratik Jain, Sriparna Roy, Leroy Leo, Sneha S K, Nathan Gomes and Puyaan Singh in Bengaluru; Editing by Shilpi Majumdar, Alan Barona, Anil D'Silva and Tasim Zahid)