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The GLP-1 market is booming, with Eli Lilly and Novo Nordisk struggling to meet surging demand, opening the door for new versions of the popular drugs. To compete with once-weekly injections, some biotech companies are looking at pills from a new angle.
Oral GLP-1 is already on the market. Novo Nordisk FDA approved Semaglutide tablets Rybelsus 2019 Last year, its indications were expanded to include early-stage treatment for lowering blood sugar levels as a treatment for type 2 diabetes. Rybelsus has the same active ingredient as Ozempic (semaglutide), but despite being more effective when administered orally, it is less widely used than Ozempic and Wegovy. Similar effects It could potentially be sold as an injectable version, according to a 2021 review of seven studies.
But Rybelsus is still objectively a blockbuster, accounting for 14% of the GLP-1 market share by the end of 2023, said Camilla Silvestre, the company’s executive vice president of commercial strategy and corporate affairs. Year-end financial results announcement In January, Rybersus sold about Sales: $2.7 billion Novo’s sales last year were $1.4 billion, compared with about $14 billion for Ozempic.
Libelsus’ market share hasn’t deterred other pharmaceutical and biotech companies from racing to perfect their own oral GLP-1s clinically. 1 in 8 American adults A recent KKF poll found that more than one million people are taking GLP-1 agonists, and JP Morgan analysts believe the GLP-1 market is $100 billion by 2030 The desire for drugs continues to grow.
When comparing oral GLP-1 to injectable GLP-1, cost is also a consideration. Over $1,000Rybersus is on par with Ozempic and Wegovi. More weight loss drugs Flood the marketBut prices may be forced down.
Injectables are difficult to manufacture and need to be kept refrigerated. On the other hand, some users may be reluctant to take injectables and prefer tablets. Also, there are several drugs in mid- and late-stage research, so some of these candidates could be launched within the next few years. Although oral GLP-1 may have the advantage in terms of convenience, pharmaceutical companies need to show that their candidates are as effective or more effective than drugs already on the market.
Below are five noteworthy oral GLP-1s in development.
Lily’s Orforgliplon
Clinical Phase: Phase 3
Path to Approval: Lilly is enrolling patients in a Phase 3 trial that is expected to have results in 2025. If the drug proves safe and effective, the company plans to launch it “probably a year after that,” CEO Dave Ricks said on the company’s most recent earnings call. Phase 2 Results Last year, participants lost weight and saw a drop in their A1C, a measure of diabetes, compared with a placebo group. The drug is one of Evaluate’s most valuable research and development projects, and the company is currently The value of Orforglipron A report earlier this year predicted it would be $13 billion.
However, this drug Not as effective According to a study published in the New England Journal of Medicine in 2023, it can be used as an injectable form of semaglutide.
“This once-daily oral formulation is only effective when taken 30 minutes before breakfast, and the approved dose (14 mg) is less effective for weight loss than the approved dose of injectable semaglutide,” wrote lead author Dr. Shawn Wharton, medical director of the Wharton Medical Clinic.
Asked how Lilly would overcome Orforgliplon’s manufacturing constraints, Ricks said the drug is complex to make but doesn’t require as much expansion as the injectable version.
Roche’s CT-996
Clinical Phase: Phase 1
The path to approval: Roche enters the GLP-1 market $2.7 billion acquisition Acquisition of Carmot Therapeutics, which closed in January. If a Phase 1 trial of an oral GLP-1 drug called CT-996 meets its endpoints, Carmot will Launch Schedule Two Phase 2 trials — one on obesity and one on type 2 diabetes.
While an oral medication is still years away from hitting the market, Roche is nearing the finish line with Calmot’s once-weekly injectable GLP-1, CT-388. Phase 1 trial results showed that CT-388 helped lower participants’ average blood sugar levels. 19% of body weight Over six months. Calmot is planning a Phase 2 trial in obese patients and a Phase 2 trial in patients with type 2 diabetes. Roche Shareholder Value The stock price has risen on the news, and the company hopes that the drug and its pipeline will allow it to enter a lucrative market alongside Lilly and Novo.
Viking Therapeutics’ VK2735
Clinical StagePhase 2 scheduled for 2024
The path to approval: Earlier this year, Viking announced results from a Phase 1 study of VK2735, a dual agonist of the GLP-1 and glucose-dependent insulinotropic polypeptide receptors. The drug stands out among other oral weight-loss candidates because it targets the GIP receptor. Weight loss was observed It was better tolerated among participants, and weight loss was more pronounced at the higher dose: 57% of participants taking the higher dose of VK2735 achieved a greater than 5% weight loss after 28 days compared to the placebo group.
The March results coincided with a rise in Viking Therapeutics’ shares. More than 25%Viking also announced that it will proceed with a Phase 2 trial in the second half of 2024, which will consider extending the treatment period and potentially increasing dosage.
Pfizer’s Danuglipron
Clinical Phase: Phase 2
The Road Ahead: In December, Pfizer announced results from its Phase 2b study of danugliplon, which showed that the trial met its primary endpoint of significant weight loss, but the company No progress The company said that the twice-daily dosing of its drug candidate had a discontinuation rate of more than 50%. A significant number of participants experienced gastrointestinal side effects from the drug, with nausea in 73% of cases, vomiting in up to 47% and diarrhea in up to 25%. Despite the bad news, Pfizer’s GLP-1 efforts aren’t over yet; the company is still moving forward with clinical trials of a once-daily version of danugliplon.
“We believe that an improved once-daily formulation of danugliplon has the potential to play an important role in the obesity treatment paradigm, and we are focused on collecting data to understand its potential profile,” Dr. Mikael Dolsten, Pfizer’s chief scientific officer and president of research and development, said in December.
The court’s findings Another blow to Pfizer The company last year halted trials of another oral GLP-1 drug, rotiglipone, after studies showed the drug was liver toxic, and is focusing on weight-loss research.
AstraZeneca’s ECC5004
Clinical Phase: Phase 2
The Road Ahead: AstraZeneca has had several GLP-1 candidates in its pipeline over the past few years, but not all have been successful. Two GLP-1 candidates last year.
The most notable candidates are License agreement with Ecogene Last year, AstraZeneca developed an investigational, once-daily, oral GLP-1 drug called ECC5004. The company paid $185 million up front, plus $1.8 billion in future clinical, regulatory and commercial milestones and royalties. AZ may be betting on the drug’s potential. Fewer intestinal side effects Compared to competitors: AZ CEO Pascal Soriot said late last year that the company would begin Phase 2 trials within the next few months.
