GLP‑1 news from 2018
10 dated, sourced GLP-1 developments from 2018: approvals, trial results, prices, lawsuits, compounding and culture.
- Science
Phase 2 tirzepatide results published in The Lancet
Frias and colleagues report the randomized, placebo- and active-comparator-controlled Phase 2 trial of LY3298176 in type 2 diabetes, the study that justified moving a dual GIP/GLP-1 agonist into Phase 3.
- Science
Lilly publishes the tirzepatide discovery paper
Coskun and colleagues describe LY3298176 in Molecular Metabolism: a 39-amino-acid peptide built by engineering GLP-1 activity into the human GIP sequence, with binding constants of 0.135 nM at the GIP receptor and 4.23 nM at the GLP-1 receptor. The paper reports preclinical work plus a three-part Phase 1 program in 142 people.
- Business
Harmony Outcomes is positive for a drug already off the market
Albiglutide reduces major adverse cardiovascular events by 22 percent in 9,463 patients, published in the Lancet. GSK had already stopped selling Tanzeum. The European marketing authorization is formally withdrawn on October 29, 2018.
- Culture
Novo Nordisk launches the Ozempic jingle, remaking a 1974 pop hit
Novo Nordisk's first Ozempic TV campaign licensed Pilot's 1974 song "Magic" and swapped the hook to "Oh, oh, oh, Ozempic." The jingle became one of the most recognizable pieces of pharmaceutical audio branding in the United States.
- Research
Novo begins the STEP trial program in obesity
Novo Nordisk launched the STEP phase 3 program to test semaglutide 2.4 mg for chronic weight management, after clinicians noticed substantial weight loss in diabetes patients on Ozempic. The program produced the data behind Wegovy.
- FDA & regulation
Japan approves Ozempic for type 2 diabetes
Japan's regulator cleared Ozempic subcutaneous injection in March 2018; Rybelsus tablets followed in June 2020.
- FDA & regulation
European Commission authorizes Ozempic EU-wide
The EU granted a marketing authorization for Ozempic about two months after the US approval.
- Research
SUSTAIN 7 publishes: semaglutide beats dulaglutide head to head
In 1,201 patients over 40 weeks, semaglutide 1.0 mg lowers A1C by 1.8 percentage points versus 1.4 with dulaglutide 1.5 mg, and cuts weight by 6.5 kg versus 3.0 kg. The trial is the clearest early signal that the next generation of GLP-1s is meaningfully stronger.
- Business
Lilly licenses orforglipron from Chugai
Eli Lilly licensed the non-peptide GLP-1 receptor agonist that would become Foundayo from Chugai Pharmaceutical Co., Ltd. of Japan. Lilly repeats the attribution in every Foundayo press release.