Is Metformin + Saxagliptin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Metformin + Saxagliptin.

Is Metformin + Saxagliptin approved by the US FDA?

Drugs@FDA lists 4 application product lines for Metformin + Saxagliptin, including SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (Prescription); SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (Prescription); KOMBIGLYZE XR (Discontinued); SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (Discontinued).

Is Metformin + Saxagliptin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Metformin + Saxagliptin: Komboglyze.

Active substances

Metformin + Saxagliptin

SFDA 6
US FDA 4
EMA 1
US price lines 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
KOMBIGLYZE XR	500,5 mg,mg	Extended-release tablet · Oral use	30 Bottle	SAR 142.55	NCE · Prescription	AstraZeneca AB	Withdrawn by MAH · Not Marketed
KOMBIGLYZE XR	1000,5 mg,mg	Extended-release tablet · Oral use	30 Bottle	SAR 146.60	NCE · Prescription	AstraZeneca AB	Withdrawn by MAH · Not Marketed
KOMBIGLYZE XR	1000,2.5 mg,mg	Extended-release tablet · Oral use	60 Bottle	SAR 152.85	NCE · Prescription	AstraZeneca AB	Withdrawn by MAH · Not Marketed
KOMBIGLYZE XR 2.5/1000MG F.C. TABLET	2.5, 1000 mg	Film-coated tablet · Oral use	60 Bottle	SAR 152.85	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
KOMBIGLYZE XR 5/1000MG F.C. TABLET	5, 1000 mg	Film-coated tablet · Oral use	30 Bottle	SAR 146.60	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
KOMBIGLYZE XR 5/500MG F.C. TABLET	5, 500 mg	Film-coated tablet · Oral use	30 Bottle	SAR 142.55	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE; 1GM;EQ 2.5MG BASE; 1GM;EQ 5MG BASE	tablet, extended release · oral	MYLAN	Prescription	31 Jul 2023
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE; 1GM;EQ 2.5MG BASE; 1GM;EQ 5MG BASE	tablet, extended release · oral	DR REDDYS LABS SA	Prescription	9 Aug 2023
KOMBIGLYZE XR	500MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 1GM;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 1GM;EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet, extended release · oral	ASTRAZENECA AB	Discontinued	5 Nov 2010
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE; 1GM;EQ 2.5MG BASE; 1GM;EQ 5MG BASE	tablet, extended release · oral	SUN PHARM	Discontinued	31 Jul 2023

EMA European Union — centrally authorised medicines

Komboglyze AstraZeneca AB · Authorised · authorised 24 Nov 2011 · ATC A10BD10

Therapeutic indication (EMA)

Komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets. Komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	SAXAGLIPTIN-METFORMIN ER 2.5-1,000 MG TABLET	$5.00702	per EA	23 Sep 2026
US NADAC	SAXAGLIPTIN-METFORMIN ER 5-1,000 MG TABLET	$9.647	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.