Encouraging clinical trial results announced on Thursday stand to open up a huge market for a convenient daily pill to treat obesity and diabetes.
The experimental drug, developed by Eli Lilly and known as orforglipron, is a type of medication known as a GLP-1. Drugs in this class like Wegovy have become hugely popular because they help people lose weight.
But those drugs must be given as weekly injections, which has limited their use. If orforglipron can deliver similar results in an easy-to-take pill form, as the study suggested it could, it has the potential to reach many more patients and become a major blockbuster.
Here’s what to know about Eli Lilly’s pill, which still must go through a review process by the Food and Drug Administration to be approved for sale.
When will the pill become available?
Eli Lilly said that it planned to seek regulatory approval to market the drug for weight loss later this year, and early next year for diabetes. The F.DA. could take months and possibly longer to review the company’s trial data before making a decision.
Wall Street analysts said that if all went smoothly, orforglipron could become available in the United States sometime in the second half of next year.
But it is unclear whether the nation’s health secretary, Robert F. Kennedy Jr., will weigh in; doing so would be highly unusual. He has criticized GLP-1 medications in the past, saying that people would be better off eating healthy food, though he said last week that they were “extraordinary drugs.”
How does the pill compare with Wegovy and Zepbound?
The most popular injectable drugs are made by Eli Lilly, which sells its product as Zepbound for obesity and Mounjaro for diabetes, and Novo Nordisk, which sells its medicine as Wegovy for obesity and as Ozempic for diabetes.
Eli Lilly’s clinical trial studied more than 500 people with Type 2 diabetes who took orforglipron or a placebo for nearly 10 months. Patients on the highest dose of orforglipron lost an average of 16 pounds, or nearly 8 percent of their body weight, according to the company.
The level of weight loss was similar to that achieved over the same period with Novo Nordisk’s injection but slightly lower than that with Eli Lilly’s injection in unrelated trials.
Did the pill cause side effects?
The company said the most common side effects observed in the clinical trial were diarrhea, indigestion, constipation, nausea and vomiting — the same problems that are common with the injectable drugs.
That was good news, because scientists and doctors have had major concerns that GLP-1 pills could cause side effects that would discourage patients from taking them or make a drug too risky to take.
This week, Pfizer said it had decided to stop developing such a pill after a trial participant experienced a “potential drug-induced liver injury.”
Lilly said its drug showed no signs of liver injury in the trial that was just reported.
How much do we know about Eli Lilly’s results?
The company issued a summary of its trial findings on Thursday in a news release, as drugmakers are required to do with data that could move their stock price. The company has not disclosed detailed scientific data — that will come later at a diabetes conference and in a medical journal — and outside experts have not reviewed it.
It is possible that when the drug is used in many more patients the benefits could be smaller, and the side effects more common or worse.
How much will the drug cost?
Eli Lilly is not likely to announce a price for the drug until it wins approval. But the medication is expected to be expensive in the United States.
When drug companies announce prices, they disclose the sticker price, which is the starting point of negotiations for coverage through insurance.
Several Wall Street analysts said they expected Eli Lilly would set a sticker price under $1,000 a month for orforglipron, lower than the sticker prices of Zepbound ($1,086) and Wegovy ($1,349).
Hardly any patients pay sticker prices. Most patients who take the injectable drugs get them through insurance, with varying out-of-pocket costs. Eli Lilly and Novo Nordisk now offer the injectable drugs for $500 in most cases for patients who pay using their own money instead of going through insurance.
How does Eli Lilly plan to manufacture its pill?
Supply shortages have been a persistent problem for the injectable GLP-1 drugs, as demand surged far beyond the drugmakers’ expectations.
Eli Lilly is trying to avoid that problem this time around with orforglipron. The company has been building up a stockpile of the pills. It recently disclosed inventory, valued at nearly $550 million, that was “primarily related to orforglipron.”
The company has not disclosed the specific locations where it’s making orforglipron, though it uses factories around the world to make its drugs. Some of the materials for manufacturing orforglipron come from Europe, according to the company. That could run into the punishing tariffs that President Trump has threatened to soon impose on imports of medications.
The company said it planned to manufacture all of the U.S. supply of orforglipron domestically within five years.
Are there other pills for weight loss?
There are older pills, like orlistat, that are approved but not widely used because most people taking them do not lose much weight and the side effects often are difficult for patients.
Another GLP-1 pill, Rybelsus, is made by Novo Nordisk and approved to treat only diabetes. It is the same drug as Wegovy and Ozempic but formulated as a pill, and results in modest weight loss.
Because most of it is broken down in the stomach, the drug has to be taken in large doses. It is not as effective as the injectable drugs, making it much less popular.
Several other companies — like AstraZeneca, Structure Therapeutics, Roche, Viking Therapeutics and Regor Therapeutics — are developing their own pill versions. But orforglipron is much further ahead in development than the others.
That means that Eli Lilly is likely to have a monopoly on the category for a few years, giving the company more leverage to keep its prices higher for longer.
“They will be the only company with an easy-to-manufacture oral GLP-1 for potentially close to three years ahead of new competitors’ entering,” said David Risinger, an analyst at Leerink Partners.
What will happen to Wegovy and Zepbound if there’s a pill?
Even if there’s a pill on the market, the injectable drugs are expected to remain popular and widely used.
Some patients like the idea of just a weekly shot, said Dr. Rudolph Leibel, a diabetes and obesity expert at Columbia University.
A fraction of patients taking injectable drugs may choose to switch to a pill. But overall the Lilly pill is expected to substantially broaden the market for GLP-1 drugs.
“It expands the pie, rather than replacing it,” said Evan Seigerman, an analyst at BMO Capital Markets.
Where did the pill come from?
Researchers at Chugai Pharmaceutical Company, a Japanese drugmaker, first discovered the drug.
Eli Lilly licensed it from Chugai in 2018. That was less than a year after Ozempic won approval to treat diabetes, and before the weight-loss effects of this class of drugs had been well recognized. Lilly paid Chugai $50 million upfront — a tiny investment compared with the considerable sales the drug is now poised to generate.
What more will we learn about this pill?
Lilly is conducting other large studies of orforglipron that have yet to report results. They include more than 10,000 patients with diabetes, and with disease combinations: diabetes and obesity, and obesity and related conditions like heart disease and sleep apnea. The company is looking at the safety and the efficacy of the drug in large and diverse patient populations.
Results in patients with obesity are expected later this year, and results from other trials of patients with Type 2 diabetes are expected early next year.
Rebecca Robbins is a reporter covering the pharmaceutical industry. She has been reporting on health and medicine since 2015.
Gina Kolata reports on diseases and treatments, how treatments are discovered and tested, and how they affect people.
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