Overview
Linagliptin is a DPP-4 inhibitor developed by Boehringer Ingelheim for the treatment of type II diabetes . Linagliptin differs from other DPP-4 inhibitors in that it has a non-linear pharmacokinetic profile, is not primarily eliminated by the renal system, and obeys concentration dependant protein binding. Linagliptin was approved by the FDA on May 2, 2011.
Indication
Linagliptin is indicated for the treatment of type II diabetes in addition to diet and exercise. It should not be used to treat type I diabetes or in diabetic ketoacidosis. An extended-release combination product containing empagliflozin, linagliptin, and metformin was approved by the FDA in January 2020 for the improvement of glycemic control in adults with type 2 diabetes mellitus when used adjunctively with diet and exercise.
Associated Conditions
- Type 2 Diabetes Mellitus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/28 | Phase 4 | Not yet recruiting | Fundación para la Investigación del Hospital Clínico de Valencia | ||
2024/02/06 | Phase 1 | Not yet recruiting | International Bio service | ||
2023/10/24 | Not Applicable | Not yet recruiting | Medanta, The Medicity, India | ||
2023/10/23 | Not Applicable | Recruiting | Medanta, The Medicity, India | ||
2023/07/21 | Phase 1 | Completed | |||
2023/06/02 | Phase 3 | Not yet recruiting | EMS | ||
2022/04/26 | N/A | UNKNOWN | |||
2022/04/06 | Not Applicable | Active, not recruiting | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
2022/01/21 | Phase 4 | UNKNOWN | |||
2021/10/11 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-4383 | ORAL | 5 mg in 1 1 | 6/26/2023 | |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0385 | ORAL | 2.5 mg in 1 1 | 10/31/2023 | |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0395 | ORAL | 2.5 mg in 1 1 | 10/31/2023 | |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0380 | ORAL | 5 mg in 1 1 | 10/31/2023 | |
| Physicians Total Care, Inc. | 54868-6461 | ORAL | 2.5 mg in 1 1 | 5/6/2015 | |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0182 | ORAL | 5 mg in 1 1 | 10/31/2023 | |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0148 | ORAL | 2.5 mg in 1 1 | 4/27/2022 | |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0147 | ORAL | 2.5 mg in 1 1 | 4/27/2022 | |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0275 | ORAL | 5 mg in 1 1 | 6/26/2023 | |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0270 | ORAL | 2.5 mg in 1 1 | 6/26/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/11/2016 | ||
Authorised | 11/11/2016 | ||
Authorised | 7/19/2012 | ||
Authorised | 8/23/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Trajenta Film-Coated Tablets 5mg | SIN14101P | TABLET, FILM COATED | 5.000mg | 2/8/2012 | |
| TRAJENTA DUO FILM-COATED TABLETS 2.5MG /850MG | SIN14378P | TABLET, FILM COATED | 2.500MG | 7/8/2013 | |
| GLYXAMBI FILM-COATED TABLETS 10 MG/5 MG | SIN15273P | TABLET, FILM COATED | 5.00 mg | 6/16/2017 | |
| TRAJENTA DUO FILM-COATED TABLETS 2.5MG / 500MG | SIN14377P | TABLET, FILM COATED | 2.500MG | 7/8/2013 | |
| GLYXAMBI FILM-COATED TABLETS 25 MG/5 MG | SIN15272P | TABLET, FILM COATED | 5.00 mg | 6/16/2017 | |
| TRAJENTA DUO FILM-COATED TABLETS 2.5MG / 1000MG | SIN14379P | TABLET, FILM COATED | 2.500MG | 7/8/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TRAJENTA DUO TAB 2.5/850MG | N/A | N/A | N/A | 5/20/2013 | |
| LINAGLIPTIN FPH TABLETS 5MG | N/A | fortune pharmacal co ltd | N/A | N/A | 10/22/2024 |
| LINAGLIPTIN SANDOZ TABLETS 5MG | N/A | N/A | N/A | 9/4/2024 | |
| LINAGLIPTIN TAISHO TABLETS 5MG | N/A | N/A | N/A | 2/26/2025 | |
| TRESOLUS TABLETS 5MG | N/A | N/A | N/A | 6/13/2025 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| TRAJENTA | boehringer ingelheim (canada) ltd ltee | 02370921 | Tablet - Oral | 5 MG | 9/13/2011 |
| GLYXAMBI | boehringer ingelheim (canada) ltd ltee | 02459760 | Tablet - Oral | 5 MG | 12/21/2016 |
| JENTADUETO | boehringer ingelheim (canada) ltd ltee | 02403269 | Tablet - Oral | 2.5 MG | 4/17/2013 |
| GLYXAMBI | boehringer ingelheim (canada) ltd ltee | 02459752 | Tablet - Oral | 5 MG | 12/21/2016 |
| JENTADUETO | boehringer ingelheim (canada) ltd ltee | 02403277 | Tablet - Oral | 2.5 MG | 4/17/2013 |
| JENTADUETO | boehringer ingelheim (canada) ltd ltee | 02403250 | Tablet - Oral | 2.5 MG | 4/17/2013 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| JENTADUETO 2,5 MG/850 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 12780006 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| LINAGLIPTINA/METFORMINA SANDOZ 2,5 MG/850 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Sandoz Farmaceutica S.A. | 90041 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LINAGLIPTINA SANDOZ 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Sandoz Farmaceutica S.A. | 90183 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LINAGLIPTINA PHARMAPATH 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Pharmapath S.A. | 89394 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LINAGLIPTINA/METFORMINA PHAROS 2,5 MG/850 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Pharos Pharmaceutical Oriented Services Ltd. | 90208 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| JENTADUETO 2,5 MG/ 1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 12780020IP3 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| JENTADUETO 2,5 MG/850 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 12780006IP4 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| LINAGLIPTINA ALTER 5 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Laboratorios Alter S.A. | 90288 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| GLYXAMBI 10 MG/5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1161146005 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| GLYXAMBI 25 MG/5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1161146014 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.