Is Alogliptin + Pioglitazone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Alogliptin + Pioglitazone, including CYERO 25/15 mg Tablet (25,15 mg,mg, Film-coated tablet, SAR 137.60); CYERO 25/30 mg Tablet (25,30 mg,mg, Film-coated tablet, SAR 159.75); INCRESYNC 25/15 mg Tablet (25,15 mg,mg, Tablet, SAR 137.60); INCRESYNC 25/30 mg Tablet (25,30 mg,mg, Tablet, SAR 159.75); INCRESYNC 25/45 mg Tablet (25,45 mg,mg, Tablet, SAR 175.75).

Is Alogliptin + Pioglitazone approved by the US FDA?

Drugs@FDA lists 2 application product lines for Alogliptin + Pioglitazone, including OSENI (Prescription); OSENI (Discontinued).

Is Alogliptin + Pioglitazone authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Alogliptin + Pioglitazone: Incresync.

Active substances

Alogliptin + Pioglitazone

SFDA 8
US FDA 2
EMA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CYERO 25/15 mg Tablet	25,15 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 137.60	NCE · Prescription	BATTERJEE PHARMACETICAL FACTORY	Valid
CYERO 25/30 mg Tablet	25,30 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 159.75	NCE · Prescription	BATTERJEE PHARMACETICAL FACTORY	Valid
INCRESYNC 25/15 mg Tablet	25,15 mg,mg	Tablet · Oral use	28 Blister	SAR 137.60	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
INCRESYNC 25/30 mg Tablet	25,30 mg,mg	Tablet · Oral use	28 Blister	SAR 159.75	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
INCRESYNC 25/45 mg Tablet	25,45 mg,mg	Tablet · Oral use	28 Blister	SAR 175.75	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
INCRESYNC 25/15 mg Tablet	25, 15 mg	Tablet · Oral use	28 Blister	SAR 137.60	NCE · Prescription	TAKEDA PHARMACEUTICALS USA, INC.	Withdrawn by MAH · Not Marketed
INCRESYNC 25/30 mg Tablet	25, 30 mg	Tablet · Oral use	28 Blister	SAR 159.75	NCE · Prescription	TAKEDA PHARMACEUTICALS USA, INC.	Withdrawn by MAH · Not Marketed
INCRESYNC 25/45 mg Tablet	25, 45 mg	Tablet · Oral use	28 Blister	SAR 175.75	NCE · Prescription	TAKEDA PHARMACEUTICALS USA, INC.	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

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

Product	Strength	Form · route	Applicant	Status	First approved
OSENI	EQ 25MG BASE;EQ 15MG BASE; EQ 25MG BASE;EQ 30MG BASE; EQ 25MG BASE;EQ 45MG BASE; EQ 12.5MG BASE;EQ 30MG BASE	tablet · oral	TAKEDA PHARMS USA	Prescription	25 Jan 2013
OSENI	EQ 12.5MG BASE;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 12.5MG BASE;EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	TAKEDA PHARMS USA	Discontinued	25 Jan 2013

EMA European Union — centrally authorised medicines

Incresync Takeda Pharma A/S · Authorised · authorised 19 Sep 2013 · ATC A10BD09

Therapeutic indication (EMA)

Incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance; in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type-2 diabetes mellitus already being treated with this combination. After initiation of therapy with Incresync, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, Incresync should be discontinued. In light of potential risks with prolonged pioglitazone therapy, prescribers should confirm at subsequent routine reviews that the benefit of Incresync is maintained (see section 4.4).

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.