What’s new

MIMRYLO - Treatment of erythrocytosis in adults with polycythemia vera. Approved as an addition to standard-of-care therapy (phlebotomy and/or cytoreductive agents), based on the Phase 3 VERIFY trial. This is a narrow hematology-oncology indication; the approval does not extend t

Rusfertide is a synthetic peptide mimetic of hepcidin, the body's principal hormonal regulator of systemic iron availability. It binds ferroportin, the sole known cellular iron exporter, and induces its internalization and degradation. By blocking ferroportin-mediated iron export

Protagonist Therapeutics, Inc.

Takeda Pharmaceutical Company Limited

ClinicalTrials.gov / Protagonist Therapeutics

U.S. National Library of Medicine (DailyMed) / Takeda Pharmaceuticals America, Inc.

A once-weekly injectable hepcidin-mimetic peptide FDA-approved to treat erythrocytosis in adults with polycythemia vera.

Tirzepatide (LY3298176) is a synthetic 39-amino acid peptide engineered as a dual agonist at the glucose-dependent insulinotropic polypeptide receptor (GIPR) and the glucagon-like peptide-1 receptor (GLP-1R). It is acylated at lysine-20 with a C20 fatty diacid chain via a linker,

Oral GLP-1

Trulicity - Type 2 diabetes (Trulicity). Reduction of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors (Trulicity), approved 2020-02-21, based on the REWIND trial.

Mounjaro, Zepbound - Type 2 diabetes (Mounjaro). Chronic weight management (Zepbound). Moderate-to-severe obstructive sleep apnea in adults with obesity (Zepbound), approved 2024-12-20, based on the SURMOUNT-OSA trials. Reduction of major adverse cardiovascular events (cardiovasc

Ozempic, Wegovy, Rybelsus - Type 2 diabetes (Ozempic). Chronic weight management (Wegovy). Cardiovascular risk reduction in adults with known cardiovascular disease and obesity or overweight (Wegovy), approved 2024-03-08, based on the SELECT trial. Reduction of the risk of kidney

FDA approved Trulicity (dulaglutide) for reduction of major adverse cardiovascular events (MACE) — nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death — in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk

FDA approved Zepbound (tirzepatide) as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity, based on the SURMOUNT-OSA trials. Reported results: reductions of roughly 25-29 apnea-hypopnea events per hour versus about

FDA approved Mounjaro (tirzepatide) to reduce the risk of major adverse cardiovascular events (MACE) — cardiovascular death, non-fatal heart attack, or non-fatal stroke — in adults with type 2 diabetes who are at high risk for these events, based on the SURPASS-CVOT trial (13,299

FDA approved Ozempic (semaglutide) for a third indication: to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease, based on the FLOW trial. This i

FDA approved Wegovy (semaglutide) 2.4 mg for an additional indication: to reduce the risk of major cardiovascular events (cardiovascular death, non-fatal heart attack, or non-fatal stroke) in adults with known cardiovascular disease and either obesity or overweight, based on the

FDA granted Wegovy (semaglutide) 2.4 mg accelerated approval to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver fibrosis, but not cirrhosis, alongside a reduced-calorie diet and increased physical activity. The approval is

FDA approved Wegovy (semaglutide) tablets, an oral once-daily 25 mg formulation, for chronic weight management in adults with obesity or overweight and at least one weight-related condition, and for reduction of major adverse cardiovascular events in adults with overweight or obe

FDA approved Wegovy HD (semaglutide injection, 7.2 mg), a higher-dose formulation, to reduce excess body weight and maintain weight reduction long-term in adults with obesity, or overweight with at least one weight-related condition. This was the fourth approval granted under the