GLP‑1 news from 2019
12 dated, sourced GLP-1 developments from 2019: approvals, trial results, prices, lawsuits, compounding and culture.
- FDA & regulation
FDA approves Rybelsus, the first oral GLP-1 receptor agonist
The FDA approved Rybelsus (semaglutide) tablets for adults with type 2 diabetes, making it the first GLP-1 receptor agonist available as a pill rather than an injection. The label required patients to take it on an empty stomach with no more than 4 ounces of plain water, then wait 30 minutes before eating.
- Science
Rybelsus arrives with strict fasting instructions
The Rybelsus label required patients to take the tablet on an empty stomach with no more than 4 ounces of plain water, then wait 30 minutes before eating, drinking or taking other medicines. Those restrictions became the main talking point when a small-molecule rival arrived in 2026.
- Business
PIONEER 4 shows a GLP-1 tablet can match an injection
The Lancet published a 711-patient trial in which oral semaglutide 14 mg was noninferior to injected liraglutide 1.8 mg on A1C and superior on weight loss at 26 weeks. It was the evidence that made a GLP-1 pill credible, and it underpinned the Rybelsus launch two months later.
- Research
Nature Medicine publishes the first human Akkermansia muciniphila trial
Depommier and colleagues report that pasteurized Akkermansia muciniphila was safe and well tolerated over three months in 32 completers, improving insulin sensitivity by 28.6% and lowering insulinemia and total cholesterol. Body weight fell 2.27 kg versus placebo but did not reach statistical significance (P=0.091).
- FDA & regulation
REWIND gives Trulicity a cardiovascular indication
In 9,901 patients followed a median of 5.4 years, dulaglutide 1.5 mg reduces major adverse cardiovascular events from 13.4 percent to 12.0 percent, hazard ratio 0.88. Most of the benefit comes from a 24 percent reduction in nonfatal stroke, and most participants did not have established cardiovascular disease at baseline.
- Research
Ellipse trial opens Victoza to children aged 10 and older
The New England Journal of Medicine published the 134-patient trial in youth aged 10 to under 17 with type 2 diabetes. A1C fell 1.06 percentage points more than placebo at 26 weeks, widening to 1.30 at 52 weeks. The result underpins Victoza's pediatric indication.
- Research
PIONEER 3 published in JAMA: oral semaglutide beats sitagliptin
In 1,864 adults, the 7 mg and 14 mg tablets beat sitagliptin on HbA1c and weight; the 3 mg starter dose did not demonstrate non-inferiority.
- FDA & regulation
FDA clears Plenity, a hydrogel weight-management device
Gelesis100 is cleared as a medical device, not approved as a drug, for adults with a BMI of 25 to 40. In the GLOW study (n=436, 24 weeks) mean weight loss was 6.4% versus 4.4% on placebo, with 59% of treated adults responding and losing an average of about 10% of body weight.
- FDA & regulation
Novo Nordisk files oral semaglutide with the FDA
Novo Nordisk submitted an application for an oral tablet form of semaglutide for blood sugar control and cardiovascular risk reduction in adults with type 2 diabetes. The tablet used an absorption enhancer to survive the stomach.
- Business
Lilly agrees to buy Loxo Oncology for about $8 billion
The largest acquisition of the Ricks era at that point, building the targeted-cancer business that later produced Retevmo and Jaypirca.
- Business
Sales reach DKK 122.0 billion as oral semaglutide is approved
Novo Nordisk's sales rose 9% in Danish kroner to DKK 122.0 billion with operating profit of DKK 52.5 billion, and the company held a 47.5% value share of the global GLP-1 market.