Sitagliptin
- Generic Name
- Sitagliptin
- Brand Names
- Janumet, Januvia, Ristaben, Steglujan, Tesavel, Velmetia, Xelevia, Sitagliptin SUN, Sitagliptin Accord, Ristfor, Efficib
- Drug Type
- Small Molecule
- Chemical Formula
- C16H15F6N5O
- CAS Number
- 486460-32-6
- Unique Ingredient Identifier
- QFP0P1DV7Z
Overview
Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar. Sitagliptin was granted FDA approval on October 16, 2006.
Background
Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose dependent increases in insulin and decreases in glucagon to improve control of blood sugar. Sitagliptin was granted FDA approval on October 16, 2006.
Indication
Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is not used to treat type 1 diabetes or patients with a history of pancreatitis. It is also used in combination with metformin or ertugliflozin.
Associated Conditions
- Type 2 Diabetes Mellitus
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2017/08/30 | Phase 4 | Completed | |||
2017/07/05 | Phase 4 | Completed | CHEOL WHAN LEE, M.D., Ph.D | ||
2017/04/24 | Phase 3 | Completed | |||
2017/04/20 | Phase 4 | Completed | |||
2017/04/14 | Phase 1 | Completed | |||
2017/04/14 | Phase 3 | Completed | Theracos | ||
2017/04/11 | Phase 4 | Completed | Sichuan Provincial People's Hospital | ||
2017/04/05 | Phase 4 | Completed | |||
2017/03/09 | Phase 3 | Completed | |||
2017/02/23 | Phase 3 | Completed |
FDA Approved Products
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Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
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No FDA products found
No FDA products found for this drug
EMA Approved Products
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Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
HSA Approved Products
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Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
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No HSA products found
No HSA products found for this drug
NMPA Approved Products
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Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
国药准字H20249136 | 片剂 | N/A | 25mg（以C₁₆H₁₅F₆N₅O计） | Chemical Drug | Approved | 2024/10/22 | Domestic | ||
国药准字H20234151 | 片剂 | N/A | 100mg（以西格列汀计） | Chemical Drug | Approved | 2023/09/12 | Domestic | ||
国药准字H20233435 | 片剂 | N/A | 25mg（按C₁₆H₁₅F₆N₅O计） | Chemical Drug | Approved | 2023/04/11 | Domestic | ||
国药准字H20233436 | 片剂 | N/A | 50mg（按C₁₆H₁₅F₆N₅O计） | Chemical Drug | Approved | 2023/04/11 | Domestic | ||
国药准字H20244935 | 片剂 | N/A | 100mg（以C₁₆H₁₅F₆N₅O计） | Chemical Drug | Approved | 2024/09/19 | Domestic | ||
H20140152 | merck sharp & dohme ltd. | 片剂 | 捷诺维 | N/A | Chemical Drug | Expired | 2018/10/25 | Import | |
H20140151 | merck sharp & dohme ltd. | 片剂 | 捷诺维 | N/A | Chemical Drug | Expired | 2018/10/25 | Import | |
国药准字H20213682 | 片剂 | N/A | 100mg（按C16H15F6N5O计） | Chemical Drug | Approved | 2021/09/01 | Domestic | ||
H20140385 | merck sharp & dohme ltd. | 片剂 | 捷诺维 | 72815片/桶 | Chemical Drug | Expired | 2018/10/25 | Import | |
J20140093 | merck sharp & dohme ltd. | 片剂 | 捷诺维 | 25mg | Chemical Drug | Approved | 2019/01/17 | Import |
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Reg. Date |
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No PPB products found
No PPB products found for this drug
TGA Approved Products
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Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|---|---|---|---|---|
408440 | Active | 2023/08/02 | sitagliptin phosphate monohydrate | ||
386879 | Active | 2023/04/06 | sitagliptin hydrochloride monohydrate | ||
220174 | Active | 2014/11/19 | sitagliptin phosphate monohydrate | ||
352350 | Active | 2024/08/08 | sitagliptin phosphate | ||
328322 | Active | 2020/11/12 | sitagliptin phosphate | ||
326501 | Active | 2021/09/13 | sitagliptin hydrochloride monohydrate | ||
297339 | Active | 2020/05/21 | sitagliptin hydrochloride monohydrate | ||
373751 | Active | 2022/07/11 | sitagliptin hydrochloride monohydrate | ||
373746 | Active | 2022/07/11 | sitagliptin hydrochloride monohydrate | ||
326502 | Active | 2021/09/13 | sitagliptin hydrochloride monohydrate |