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.
Background
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 | 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 |
|---|---|---|---|---|---|
| Linagliptin Tablets | 国药准字H20249802 | 化学药品 | 片剂 | 12/25/2024 | |
| Linagliptin Tablets | 国药准字H20253271 | 化学药品 | 片剂 | 1/24/2025 | |
| Linagliptin Tablets | 国药准字H20233760 | 化学药品 | 片剂 | 6/21/2023 | |
| Linagliptin Tablets | 国药准字H20203294 | 化学药品 | 片剂 | 7/8/2020 | |
| Linagliptin Tablets | 国药准字H20223036 | 化学药品 | 片剂 | 1/30/2022 | |
| Linagliptin Tablets | 国药准字H20223786 | 化学药品 | 片剂 | 11/1/2022 | |
| Linagliptin Tablets | 国药准字H20249165 | 化学药品 | 片剂 | 10/22/2024 | |
| Linagliptin Tablets | 国药准字H20213378 | 化学药品 | 片剂 | 5/19/2021 | |
| Linagliptin Tablets | 国药准字H20223471 | 化学药品 | 片剂 | 7/5/2022 | |
| Linagliptin Tablets | 国药准字H20243434 | 化学药品 | 片剂 | 4/7/2024 |
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 |