| Product Name | Saxagliptin (BMS-477118) |
| CAS Number | 361442-04-8 |
| Molecular Formula | C₁₈H₂₅N₃O₂ |
| Molecular Weight | 315.4 g/mol (anhydrous) |
| Development Code | BMS-477118 |
| Appearance | White to off-white / pale yellow solid powder |
| Purity | 98–99% (by HPLC) |
| Solubility | DMSO: 2 mg/mL, clear; Insoluble in water and ethanol |
| UNII | 9GB927LAJW |
| Storage Conditions | Short-term (days–weeks): 0–4°C; Long-term (months): –20°C |
Products Description
What Is Saxagliptin BMS-477118?
Saxagliptin (BMS-477118) is a potent, selective, reversible, and orally active inhibitor of dipeptidyl peptidase 4 (DPP-4) .
Originally approved for the treatment of Type 2 Diabetes Mellitus, Saxagliptin works by inhibiting the DPP-4 enzyme, which prolongs the half-life of incretin hormones (GLP-1 and GIP), thereby stimulating insulin secretion and suppressing glucagon release.
Applications Of Saxagliptin BMS-477118
1.Approved Application: Type 2 Diabetes Mellitus
1.1Regulatory Approval Status
| Application Type | Regimen | Evidence |
|---|---|---|
| Monotherapy | Adjunct to diet and exercise for glycemic control | Phase 3 trial validated |
| Add-on to Insulin | Saxagliptin 5mg + Insulin (± Metformin) | Phase 3 (NCT00757588), n=455 |
| Add-on to Metformin IR | Saxagliptin 2.5mg BID + Metformin IR | Phase 3 (NCT00885378), n=166 |
| Add-on to Dapagliflozin | Saxagliptin 5mg + Dapagliflozin 10mg | Fixed-dose combination Qtern® |
1.2Phase 3 Clinical Data: Saxagliptin + Insulin (NCT00757588)
Multicenter, randomized, double-blind Phase 3 trial in 455 T2DM patients:
| Endpoint | Placebo + Insulin | Saxagliptin 5mg + Insulin | Difference |
|---|---|---|---|
| HbA1c Change (adj. mean) | -0.32% | -0.73% | -0.41% |
| Fasting Glucose Change | -6.1 mg/dL | -10.1 mg/dL | -4.0 mg/dL |
| Postprandial Glucose AUC | -718.8 mg·min/dL | -4,548.5 mg·min/dL | -3,829.7 |
| HbA1c <7% Achievers | 6.7% | 17.3% | +10.6% |
| Insulin Dose Change | +5.01 units | +1.71 units | 3.3 units saved/day |
1.3Phase 3 Clinical Data: Saxagliptin + Metformin (NCT00885378)
Phase 3 trial in 166 T2DM patients inadequately controlled on metformin alone:
| Endpoint | Placebo + Metformin IR | Saxagliptin 2.5mg BID + Metformin IR |
|---|---|---|
| Fasting Glucose Change (adj. mean) | -4.22 mg/dL | -13.73 mg/dL |
| HbA1c <7% Achievers | 24.2% | 37.5% |
| HbA1c ≤6.5% Achievers | 10.7% | 24.6% |
Safety Summary:
| Event | Placebo + Metformin | Saxagliptin + Metformin |
|---|---|---|
| ≥1 Adverse Event | 34 patients | 19 patients |
| Related Adverse Events | 3 patients | 1 patient |
| Serious Adverse Events | 1 patient | 1 patient |
| Hypoglycemia Events | 1 patient | 4 patients |
2.For User Search
| Search Intent Type | Typical Query |
| Approved Indications | "Saxagliptin diabetes" / "Onglyza" |
| Clinical Application Data | "Saxagliptin Phase 3 trial" / "clinical trial results" |
| Emerging Research | "Saxagliptin colitis" / "DPP-4 inhibitor inflammation" |
| Combination Therapy | "Saxagliptin combination" / "Qtern" / "Kombiglyze XR" |
| Safety Information | "Saxagliptin safety" / "hypoglycemia risk" |
Safety & Tolerability Benefits of Saxagliptin BMS-477118
Saxagliptin offers a favorable safety profile compared to other antidiabetic agents:
| Parameter | Benefit |
|---|---|
| Hypoglycemia Risk | Very low (glucose-dependent mechanism) . |
| Weight Effect | Neutral (no weight gain) . |
| Cardiovascular Safety | Minimal adverse effects compared to other antidiabetic agents . |
| Tolerability | Generally well-tolerated; adverse events similar to placebo . |
| Drug-Drug Interactions | Well-characterized; requires dose adjustment with strong CYP3A4 inhibitors. |
Customer Feedback
CONTACT PAGE
1.Inquiry methods：
Email:alice@xaheshun.com
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Online instant messaging
2.Contact Information：
Name：Alice
Telephone :+8618509260106
Email:alice@xaheshun.com
FAQ
Q: What is the CAS number of Saxagliptin and which form do I need?
A:Free base: CAS 361442-04-8 for general research.
Hydrate: CAS 945667-22-1 for standard reference.
Hydrochloride (HCl): CAS 709031-78-7 with higher water solubility for in vivo studies.
Q: Which pharmacopeia standards does your Saxagliptin API comply with?
A: Our Saxagliptin API (BMS-477118) is manufactured in strict compliance with current USP (United States Pharmacopeia) and EP (European Pharmacopoeia) standards. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) specifying its compliance with international quality criteria.
Q: Is your Saxagliptin API supplied as the monohydrate or anhydrous form?
A: We commercially supply Saxagliptin Monohydrate which is the thermodynamically stable crystalline form utilized in the innovator drug (Onglyza). This ensures bioequivalence and formulation stability during blending and tableting. Custom crystalline or amorphous forms can be evaluated upon request.
Q: What is the commercial scale capability and MOQ for Saxagliptin BMS-477118?
A: Our state-of-the-art facility supports seamless scaling from gram-scale samples for R&D/pilot trials to multi-kilogram commercial batches for large-scale generic manufacturing. Our standard commercial Minimum Order Quantity (MOQ) starts at 1 kg, with flexible arrangements for early-stage formulation development.
Q: Can Saxagliptin be used for human therapeutic purposes?
A: No. For research use only.
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