BioPharmaPT
โ† All metabolic drugs

Insulins

Metabolicยท 8 reviewed drugsยท 8389 cited findings behind them

What the regulatory reviews cover

The Insulins in this library, including Tresiba, Ryzodeg, Xultophy, Kyinsu, Awiqli, Suliqua, Fiasp, and LANTUS, have undergone regulatory review for various indications related to diabetes mellitus. These indications range from improving glycemic control in patients 1 year of age and older with diabetes mellitus (Tresiba) to the treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or GLP-1 receptor agonists (Kyinsu).

Regulatory reviews report on a variety of outcomes. For instance, Tresiba showed an HbA1c change from baseline of -0.57. Ryzodeg demonstrated a day-to-day variability in glucose-lowering effect (AUCGIR,ฯ„,SS) (CV%) of 20, compared to 82 for comparator IGlar. Fiasp had an HbA1c treatment difference (meal-time Fiasp vs meal-time NovoLog) of -0.17, while LANTUS reported an HbA1c adjusted mean change from baseline (Study A) of +0.21. It is important to note that different drugs were studied in different trials, and therefore, the figures presented are not head-to-head comparisons.

The drugs โ€” one cited result each

Tresiba

NOVO

HbA1c change from baseline: -0.57

NOVO โ€” Tresiba FDA Review (NDA/BLA 203314, 2018), p.31

Ryzodeg

Novo Nordisk A S

Day-to-day variability in glucose-lowering effect (AUCGIR,ฯ„,SS) (CV%): 20

Novo Nordisk A S โ€” Ryzodeg EMA EPAR public assessment report, p.37

Xultophy

Novo Nordisk A S

HbA1c reduction from baseline (liraglutide): -1.16

Novo Nordisk A S โ€” Xultophy EMA EPAR variation assessment re, p.41

Kyinsu

Novo Nordisk A S

HbA1c change from baseline (Kyinsu): -1.55

Novo Nordisk A S โ€” Kyinsu EMA EPAR public assessment report, p.83

Awiqli

Novo Nordisk A S

Potency of insulin icodec vs NPH human insulin (HbA1c reduction): 40-50

Novo Nordisk A S โ€” Awiqli EMA EPAR public assessment report, p.31

Suliqua

Sanofi

LS mean difference in HbA1c (%) (FRC - insulin glargine): -0.29

Sanofi โ€” Suliqua EMA EPAR public assessment report (EMEA/H/C, p.72

Fiasp

NOVO

HbA1c treatment difference (meal-time Fiasp vs meal-time NovoLog): -0.17

NOVO โ€” Fiasp FDA Review (NDA/BLA 208751, 2026), p.9

LANTUS

Sanofi

HbA1c adjusted mean change from baseline (Study A): +0.21

Lantus FDA Review, p.19

Different drugs were studied in different trials โ€” these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs โ€” searchable, comparable and answerable in plain language โ€” is in the Metabolic research library โ†’

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ€” not medical or investment advice.

Insulins โ€” 8 Drugs Compared from FDA & EMA Reviews | BioPharmaPT Metabolic