Is Alogliptin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Alogliptin, including VIPIDIA 12.5 mg film-coated tablet (12.5 mg, Film-coated tablet, SAR 52.90); VIPIDIA 25 mg film-coated tablet (25 mg, Film-coated tablet, SAR 105.85); ZYTERO 12.5 mg Film Coated Tablet (12.5 mg, Film-coated tablet, SAR 52.90); ZYTERO 25 mg Film Coated Tablet (25 mg, Film-coated tablet, SAR 105.85).

Is Alogliptin approved by the US FDA?

Drugs@FDA lists 1 application product line for Alogliptin, including NESINA (Prescription).

Is Alogliptin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Alogliptin: Vipidia.

Are there safety signals or safety updates for Alogliptin?

EMA PRAC: 2 entries; US FDA: 3 entries (latest 2026-08-11).

Active substance

Alogliptin

SFDA 6
US FDA 1
EMA 1
Health Canada 3
US price lines 3
NHS prices 3
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
VIPIDIA 12.5 mg film-coated tablet	12.5 mg	Film-coated tablet · Oral use	28 Blister	SAR 52.90	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
VIPIDIA 25 mg film-coated tablet	25 mg	Film-coated tablet · Oral use	28 Blister	SAR 105.85	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
ZYTERO 12.5 mg Film Coated Tablet	12.5 mg	Film-coated tablet · Oral use	28 Blister	SAR 52.90	NCE · Prescription	BATTERJEE PHARMACETICAL FACTORY	Valid
ZYTERO 25 mg Film Coated Tablet	25 mg	Film-coated tablet · Oral use	28 Blister	SAR 105.85	NCE · Prescription	BATTERJEE PHARMACETICAL FACTORY	Valid
VIPIDIA 12.5 mg film-coated tablet	12.5 mg	Film-coated tablet · Oral use	28 Blister	SAR 52.90	NCE · Prescription	TAKEDA PHARMACEUTICALS USA, INC.	Withdrawn by MAH · Not Marketed
VIPIDIA 25 mg film-coated tablet	25 mg	Film-coated tablet · Oral use	28 Blister	SAR 105.85	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	Withdrawn by MAH · Not Marketed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
NESINA	EQ 6.25MG BASE; EQ 12.5MG BASE; EQ 25MG BASE	tablet · oral	TAKEDA PHARMS USA	Prescription	25 Jan 2013

EMA European Union — centrally authorised medicines

Vipidia Takeda Pharma A/S · Authorised · authorised 18 Sep 2013 · ATC A10BH04

Therapeutic indication (EMA)

Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NESINA	02417189	6.25 MG	TABLET · ORAL	TAKEDA CANADA INC
NESINA	02417197	12.5 MG	TABLET · ORAL	TAKEDA CANADA INC
NESINA	02417200	25 MG	TABLET · ORAL	TAKEDA CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ALOGLIPTIN 12.5 MG TABLET	$4.95683	per EA	23 Sep 2026
US NADAC	ALOGLIPTIN 25 MG TABLET	$4.9069	per EA	23 Sep 2026
US NADAC	ALOGLIPTIN 6.25 MG TABLET	$5.27823	per EA	23 Sep 2026
NHS Drug Tariff	Alogliptin 12.5mg tablets	£26.60	28 tablet	1 Oct 2026
NHS Drug Tariff	Alogliptin 25mg tablets	£26.60	28 tablet	1 Oct 2026
NHS Drug Tariff	Alogliptin 6.25mg tablets	£26.60	28 tablet	1 Oct 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.

Safety signals and safety-related labeling changes

US FDA 11 Aug 2026 KAZANO — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Jun 2024 OSENI — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Jul 2023 NESINA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Feb 2016 PRAC signal: Arthralgia
Action for MAH: update of the product information: No
EMA PRAC 8 Oct 2015 PRAC signal: Arthralgia
Action for MAH: update of the product information: No

All safety entries for alogliptin →

Combinations containing Alogliptin

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.