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

April 1 (Reuters) - The weight-loss drug market is surging, with biotech firms racing to win share in a sector dominated by Novo Nordisk NOVOb.CO and Eli Lilly LLY.N.

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

Eli Lilly on Wednesday became the second company to secure approval for a weight-loss pill, as the multibillion-dollar market shifts toward more convenient oral therapies.

Novo Nordisk won a key first-mover advantage after U.S. Food and Drug Administration approved a pill version of its blockbuster obesity injection Wegovy in December.

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 FDA approved the oral version of Novo Nordisk's injectable weight loss drug Wegovy in December.

The company is also developing several experimental weight-loss drugs, a next-generation injection called amycretin, and CagriSema, touted as a potent successor to Wegovy.

Amycretin, which targets GLP-1 and amylin hormones, showed statistically significant weight loss of up to 14.5% at 36 weeks in patients with type 2 diabetes in a mid-stage study.

CagriSema 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.

Novo also 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

Through a buyout, the company gained access to Metsera'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.

Pfizer in December entered into an exclusive licensing agreement with YaoPharma, a subsidiary of China's Shanghai Fosun Pharmaceutical 600196.SS, to develop and commercialize an experimental weight-management treatment.

ELI LILLY

Lilly's orforglipron, branded as Foundayo, became the second oral pill for weight-loss to gain U.S. approval.

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.

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 2105.HK 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 ROG.S 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 last year, Roche ROG.S acquired rights to Zealand Pharma's ZELA.CO obesity treatment, petrelintide, in a deal potentially worth up to $5.3 billion.

AMGEN

Last year, Amgen's AMGN.O 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

In 2024, Merck MRK.N signed a licensing deal worth up to $2 billion for Chinese biotech Hansoh Pharma's 3692.HK 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.

VIKING THERAPEUTICS

In August, Viking Therapeutics VKTX.O 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 SRRK.O 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.

STRUCTURE THERAPEUTICS

Structure Therapeutics said in December 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.