Steglatro

Metabolic· 1185 cited findings· 1 source document

What the regulatory reviews say

Steglatro (ertugliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated for the treatment of type 2 diabetes mellitus. It works by inhibiting SGLT2, with an IC50 for human SGLT2 of 0.877 ± 0.369 nM, demonstrating high selectivity over SGLT1 (IC50 1960 ± 642 nM). In clinical trials, Steglatro led to a change from baseline in FPG of -7.70 mg/dL and a change from baseline in HbA1c of 0.20%.

Notable safety findings include a rate of hypoglycemia of 5.0% for ertugliflozin 5mg and 4.5% for ertugliflozin 15mg, compared to 2.9% for placebo. The incidence of genital infections in female patients treated with ertugliflozin 5mg was 9.1%. Discontinuation due to adverse events ranged from 0.4% to 3.2% across different studies.

The Marketing Authorization Application for Steglatro was submitted on 1 February 2017, and the CHMP issued a positive opinion for marketing authorization on 25 January 2018. Steglatro is available in 5 mg (triangular, pink) and 15 mg (triangular, red) film-coated tablets, with a proposed shelf-life of 2 years.

Key figures — cited to the source page

Ertugliflozin IC50 for human SGLT2	0.877 ± 0.369	Merck & Co., Inc. — Steglatro EMA EPAR public assessment rep, p.16
FPG change from baseline	-7.70	Merck & Co., Inc. — Steglatro EMA EPAR public assessment rep, p.65
HbA1c change from baseline	0.20	Merck & Co., Inc. — Steglatro EMA EPAR public assessment rep, p.59
Rate of hypoglycemia (ertugliflozin 5mg)	5.0	Merck & Co., Inc. — Steglatro EMA EPAR public assessment rep, p.134
Rate of hypoglycemia (placebo)	2.9	Merck & Co., Inc. — Steglatro EMA EPAR public assessment rep, p.134
Incidence of genital infections (female, ertugliflozin 5mg)	9.1	Merck & Co., Inc. — Steglatro EMA EPAR public assessment rep, p.134
Marketing authorization application submission date	1 February 2017	Merck & Co., Inc. — Steglatro EMA EPAR public assessment rep, p.6
CHMP positive opinion date for marketing authorization	25 January 2018	Merck & Co., Inc. — Steglatro EMA EPAR public assessment rep, p.7

Source documents

Merck & Co., Inc. — Steglatro EMA EPAR public assessment report (EMEA/H/C/004315, 2018) (2018)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.