Glossary
The vocabulary of the monographs, defined once.
- Accelerated approval
- An FDA approval based on an intermediate or surrogate endpoint, where continued approval may depend on a confirmatory trial. Elamipretide (Forzinity) was approved this way, on knee-extensor strength1FDAFORZINITY prescribing information: Indications and Usage. FDA-approved labeling via openFDA/DailyMed, version effective 2025-12-10..
- Agonist
- A molecule that binds a receptor and activates it. Semaglutide is a GLP-1 receptor agonist2FDAOZEMPIC prescribing information: Indications and Usage. FDA-approved labeling via openFDA/DailyMed, version effective 2026-07-30..
- Amylin
- A pancreatic hormone that induces satiety; cagrilintide is a long-acting analog of it3PubMedOnce-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lau DCW et al. Lancet. 2021..
- Category 2 (FDA compounding)
- FDA’s list of bulk drug substances nominated for compounding that may present significant safety risks; the same page lists nominations that were withdrawn4FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. FDA, content current as of 04/22/2026..
- Cardiolipin
- A phospholipid of the inner mitochondrial membrane. Barth syndrome involves abnormal cardiolipin5PubMedA phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism. Reid Thompson W et al. Genet Med. 2021..
- Crossover trial
- A trial in which each participant receives both treatments in sequence, separated by a washout — as in part 1 of TAZPOWER5.
- GHRH
- Growth-hormone-releasing hormone, which stimulates the anterior pituitary to secrete growth hormone. Sermorelin is its 29-residue active fragment6PubMedSermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. Prakash A & Goa KL BioDrugs. 1999..
- GH secretagogue (ghrelin) receptor
- A second pituitary route to growth hormone release, targeted by ipamorelin and GHRP-67PubMedIpamorelin, the first selective growth hormone secretagogue. Raun K et al. Eur J Endocrinol. 1998..
- Half-life
- The time for the concentration of a drug in the body to halve; it sets dosing frequency. Semaglutide’s is about 7 days8PubMedPharmacokinetics and Clinical Implications of Semaglutide: A New Glucagon-Like Peptide (GLP)-1 Receptor Agonist. Hall S et al. Clin Pharmacokinet. 2018..
- HbA1c
- Glycated hemoglobin, a measure of average blood glucose over recent months and the usual primary endpoint in diabetes trials such as SURPASS-29PubMedTirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. Frías JP et al. N Engl J Med. 2021..
- Incretin
- A gut hormone, such as GLP-1 or GIP, that amplifies insulin release after eating.
- MACE
- Major adverse cardiovascular events: in SELECT, cardiovascular death, non-fatal myocardial infarction or non-fatal stroke10PubMedSemaglutide and Cardiovascular Outcomes in Obesity without Diabetes. Lincoff AM et al. N Engl J Med. 2023..
- Open-label
- A trial in which participants and investigators know which treatment is given. SURMOUNT-5 was open-label11PubMedTirzepatide as Compared with Semaglutide for the Treatment of Obesity. Aronne LJ et al. N Engl J Med. 2025..
- Phase 1, 2, 3
- Stages of clinical development: phase 1 tests safety and pharmacology, usually in small groups; phase 2 explores dose and efficacy; phase 3 confirms efficacy in large randomized trials.
- Placebo-controlled
- Compared against an inactive treatment so that effects of the drug can be separated from other influences.
- Randomized controlled trial (RCT)
- A trial that assigns participants to treatments by chance, the basis of our Grade B.
- Six-minute walk test (6MWT)
- Distance walked in six minutes; a functional endpoint used in elamipretide trials12PubMedEfficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. Karaa A et al. Neurology. 2023..
- Visceral adipose tissue
- Fat around the abdominal organs, measured by imaging; the primary endpoint in tesamorelin’s phase 3 trials13PubMedEffects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. Falutz J et al. J Clin Endocrinol Metab. 2010..
References
Every source below was retrieved from its official API or page and cached on the data-edition date. Numbers match the margin notes.
- 1 FDA FORZINITY prescribing information: Indications and Usage. FDA-approved labeling via openFDA/DailyMed, version effective 2025-12-10.
- 2 FDA OZEMPIC prescribing information: Indications and Usage. FDA-approved labeling via openFDA/DailyMed, version effective 2026-07-30.
- 3 PubMed Lau DCW, Erichsen L, Francisco AM, et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet 2021. PMID 34798060; doi:10.1016/S0140-6736(21)01751-7.
- 4 FDA Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. FDA, content current as of 04/22/2026.
- 5 PubMed Reid Thompson W, Hornby B, Manuel R, et al. A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism. Genet Med 2021. PMID 33077895; doi:10.1038/s41436-020-01006-8.
- 6 PubMed Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs 1999. PMID 18031173; doi:10.2165/00063030-199912020-00007.
- 7 PubMed Raun K, Hansen BS, Johansen NL, et al. Ipamorelin, the first selective growth hormone secretagogue. Eur J Endocrinol 1998. PMID 9849822; doi:10.1530/eje.0.1390552.
- 8 PubMed Hall S, Isaacs D, Clements JN. Pharmacokinetics and Clinical Implications of Semaglutide: A New Glucagon-Like Peptide (GLP)-1 Receptor Agonist. Clin Pharmacokinet 2018. PMID 29915923; doi:10.1007/s40262-018-0668-z.
- 9 PubMed Frías JP, Davies MJ, Rosenstock J, et al. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. N Engl J Med 2021. PMID 34170647; doi:10.1056/NEJMoa2107519.
- 10 PubMed Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med 2023. PMID 37952131; doi:10.1056/NEJMoa2307563.
- 11 PubMed Aronne LJ, Horn DB, le Roux CW, et al. Tirzepatide as Compared with Semaglutide for the Treatment of Obesity. N Engl J Med 2025. PMID 40353578; doi:10.1056/NEJMoa2416394.
- 12 PubMed Karaa A, Bertini E, Carelli V, et al. Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. Neurology 2023. PMID 37268435; doi:10.1212/WNL.0000000000207402.
- 13 PubMed Falutz J, Mamputu JC, Potvin D, et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab 2010. PMID 20554713; doi:10.1210/jc.2010-0490.