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Dapagliflozin | CAS No: 461432-26-8 | GMP-certified suppliers
A medication that supports glycemic control in type 2 diabetes and helps reduce cardiorenal risks, including kidney disease progression and heart failure events in adults.
Therapeutic categories
Primary indications
- Dapagliflozin is indicated as an adjunct treatment to improve glycemic control in adult patients with type 2 diabetes mellitus along with diet and exercise
- For patients with chronic kidney disease at risk of progression, dapagliflozin in used to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure
- Dapagliflozin is also indicated to either reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors
- Combination products with dapagliflozin also exist, either as a dapagliflozin-saxagliptin or dapagliflozin-metformin hydrochloride formulation
Product Snapshot
- Oral small‑molecule formulation supplied primarily as film‑coated tablets
- Therapeutic use focuses on glycemic control in type 2 diabetes, with additional utility in chronic kidney disease and heart‑failure risk reduction
- Approved in major regulated markets including the US, EU, and Canada
Clinical Overview
Dapagliflozin is a phenolic glycoside that inhibits SGLT2 in the proximal renal tubule, blocking reabsorption of filtered glucose and promoting urinary glucose excretion. SGLT2 is responsible for the majority of renal glucose reuptake, and its inhibition produces sustained glucosuria that enhances glycemic regulation. Resulting natriuresis increases sodium delivery to the distal nephron, influencing hemodynamic parameters such as preload, afterload, and intraglomerular pressure via augmented tubuloglomerular feedback.
Glucose excretion observed with 5 to 10 mg daily doses averages about 70 grams per day after 12 weeks of therapy. Urinary volume increases in parallel. After discontinuation, urinary glucose excretion typically returns to baseline within several days. Dapagliflozin has not shown clinically meaningful QTc prolongation at exposures well above the recommended therapeutic range.
Absorption, metabolism, and elimination are primarily driven by oral bioavailability with metabolic clearance through glucuronidation pathways, including UGT1A9 and UGT2B7. It is also a substrate of P‑glycoprotein and several cytochrome P450 isoforms, though these pathways do not appear to dominate systemic clearance.
Safety considerations include risks associated with volume depletion, genitourinary infections, and rare ketoacidosis. Monitoring renal function is essential, particularly in populations with impaired kidney function.
For API procurement, sourcing should prioritize manufacturers with demonstrable control of stereochemistry, impurity profiles, and consistency in glycoside stability, supported by full regulatory documentation and validated analytical methods.
Identification & chemistry
| Generic name | Dapagliflozin |
|---|---|
| Molecule type | Small molecule |
| CAS | 461432-26-8 |
| UNII | 1ULL0QJ8UC |
| DrugBank ID | DB06292 |
Pharmacology
| Summary | Dapagliflozin is an SGLT2 inhibitor that reduces renal glucose and sodium reabsorption, leading to increased urinary glucose excretion and associated changes in intrarenal sodium handling. By lowering proximal tubular reabsorption, it influences tubuloglomerular feedback, intraglomerular pressure, and hemodynamic load. These pharmacologic actions support its therapeutic use in type 2 diabetes, chronic kidney disease, and heart failure. |
|---|---|
| Mechanism of action | Dapagliflozin inhibits the sodium-glucose cotransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron.SGLT2 facilitates 90% of glucose reabsorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine.This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus. |
| Pharmacodynamics | Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not restricted to, lowering both pre- and afterload of the heart and downregulation of sympathetic activity, and decreased intraglomerular pressure which is believed to be mediated by increased tubuloglomerular feedback. Increases in the amount of glucose excreted in the urine were observed in healthy subjects and in patients with type 2 diabetes mellitus following the administration of dapagliflozin. Dapagliflozin doses of 5 or 10 mg per day in patients with type 2 diabetes mellitus for 12 weeks resulted in excretion of approximately 70 grams of glucose in the urine per day at Week 12. A near-maximum glucose excretion was observed at the dapagliflozin daily dose of 20 mg. This urinary glucose excretion with dapagliflozin also results in increases in urinary volume. After discontinuation of dapagliflozin, on average, the elevation in urinary glucose excretion approaches baseline by about 3 days for the 10 mg dose. Dapagliflozin was not associated with clinically meaningful prolongation of QTc interval at daily doses up to 150 mg (15 times the recommended maximum dose) in a study of healthy subjects. In addition, no clinically meaningful effect on QTc interval was observed following single doses of up to 500 mg (50 times the recommended maximum dose) of dapagliflozin in healthy subjects. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium/glucose cotransporter 2 | Humans | antagonist, inhibitor |
ADME / PK
| Absorption | Oral dapagliflozin reaches a maximum concentration within 1 hour of administration when patients have been fasting.Following oral administration of dapagliflozin, the maximum plasma concentration (C<sub>max</sub>) is usually attained within 2 hours under fasting state. The C<sub>max</sub> and AUC values increase dose proportionally with an increase in dapagliflozin dose in the therapeutic dose range. The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78%. Administration of dapagliflozin with a high-fat meal decreases its C<sub>max</sub> by up to 50% and prolongs T<sub>max</sub> by approximately 1 hour but does not alter AUC as compared with the fasted state. These changes are not considered to be clinically meaningful and dapagliflozin can be administered with or without food. |
|---|---|
| Half-life | The mean plasma terminal half-life (t<sub>1/2</sub>) for dapagliflozin is approximately 12.9 hours following a single oral dose of 10 mg.In healthy subjects given a single oral dose of 50 mg of dapagliflozin, the mean terminal half-life was 13.8 hours. |
| Protein binding | Dapagliflozin is approximately 91% protein bound. Protein binding is not altered in patients with renal or hepatic impairment. |
| Metabolism | Dapagliflozin is primarily glucuronidated to become the inactive 3-O-glucuronide metabolite(60.7%).Dapagliflozin also produces another minor glucuronidated metabolite(5.4%), a de-ethylated metabolite(<5%), and a hydroxylated metabolite(<5%). Metabolism of dapagliflozin is mediated by cytochrome p-450(CYP)1A1, CYP1A2, CYP2A6, CYP2C9, CYP2D6, CYP3A4, uridine diphosphate glucuronyltransferase(UGT)1A9, UGT2B4, and UGT2B7. Glucuronidation to the major metabolite is mediated by UGT1A9. |
| Route of elimination | Dapagliflozin and related metabolites are primarily eliminated via the renal pathway. Following a single 50 mg dose of [<sup>14</sup>C]-dapagliflozin, 75% and 21% of total radioactivity is excreted in urine and feces, respectively. In urine, less than 2% of the dose is excreted as the parent drug. In feces, approximately 15% of the dose is excreted as the parent drug. |
| Volume of distribution | The volume of distribution was estimated to be 118L. |
| Clearance | Oral plasma clearance was 4.9 mL/min/kg, and renal clearance was 5.6 mL/min. |
Formulation & handling
- Oral small‑molecule API with moderate lipophilicity and low aqueous solubility, typically formulated as film‑coated tablets including extended‑release designs to control dissolution.
- Low water solubility may require solubility‑enhancing approaches such as solid dispersion, polymer matrices, or optimized granulation for robust tablet performance.
- Chemically stable solid phenolic glycoside; standard protection from moisture is recommended to maintain solid‑state stability during storage and processing.
Regulatory status
| Lifecycle | Key U.S. patents protecting the API extend through 2030, indicating remaining exclusivity despite several earlier expirations. With commercialization across the US, EU, and Canada, the product is in a mature market phase but retains some patent‑based protection in the United States. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Dapagliflozin was developed by a single originator, with numerous branded and non‑originator products now present across the US, EU, and Canada, indicating established global market penetration. Multiple Canadian brand variants suggest active generic participation, while the staggered US patent expiries—some completed and others extending to 2030—point to a mixed landscape of existing generics and continued protection for certain claims. This creates a supply environment where originator and generic manufacturers operate in parallel depending on market and patent status. |
|---|
Safety
| Toxicity | Age, gender, race, and body weight do not affect dapagliflozin dosing requirements[Label,A6758]. Although age does not affect dosing requirements, safety has not been established in pediatric populations and patients at an especially advanced age may be more susceptible to adverse effects[Label]. Animal studies in pregnancy showed no fetal toxicity in the first trimester but exposure later in pregnancy was associated with renal pelvic dilatation and maternal toxicity at much higher doses than the maximum recommended human dose[Label]. Due to this data, dapagliflozin is not recommended in the second and third trimester of pregnancy[Label]. Dapagliflozin is excreted in milk from rats, though this may not necessarily be the case in humans[Label]. Children under 2 years old who are exposed to dapagliflozin may be at risk of improper kidney development[Label]. Dapagliflozin is not recommended in patients with a creatinine clearance below 45mL/min and is contraindicated in patients with creatinine clearance below 30mL/min[Label]. Dose adjustments are not necessary in patients with hepatic impairment at any stage, although the risk and benefit to the patient must be assessed as there is limited data on dapagliflozin use in this population[Label]. |
|---|
- Safety in pediatric populations is unestablished
- Animal and developmental data indicate potential renal effects from exposure during early life stages
- Late‑gestation exposure in animal studies produced renal pelvic dilatation and maternal toxicity at doses above human exposure levels
Dapagliflozin is a type of SGLT2-inhibitors
SGLT2 inhibitors, short for Sodium-Glucose Co-Transporter 2 inhibitors, belong to the pharmaceutical API subcategory utilized in the treatment of type 2 diabetes mellitus (T2DM). These innovative drugs target the SGLT2 protein responsible for reabsorbing glucose in the kidneys, resulting in increased urinary glucose excretion.
By inhibiting SGLT2, these drugs effectively lower blood glucose levels and improve glycemic control in patients with T2DM. This mechanism of action is independent of insulin secretion or sensitivity, making SGLT2 inhibitors an attractive option for individuals who are resistant to or cannot tolerate other diabetes medications.
Some commonly prescribed SGLT2 inhibitors include canagliflozin, dapagliflozin, and empagliflozin. These pharmaceutical APIs are typically formulated into oral tablets, making them convenient for patient administration.
Clinical studies have demonstrated the effectiveness of SGLT2 inhibitors in reducing HbA1c levels, body weight, and blood pressure in patients with T2DM. Additionally, these medications have shown potential cardiovascular benefits, including a decreased risk of cardiovascular events.
However, it is important to note that SGLT2 inhibitors are not suitable for everyone, and their use should be carefully considered in patients with renal impairment or a history of ketoacidosis. Adverse effects may include genitourinary infections and increased risk of dehydration.
Overall, SGLT2 inhibitors are a promising class of pharmaceutical APIs that offer an innovative approach to managing T2DM by targeting renal glucose reabsorption. Ongoing research and development in this field aim to further optimize the therapeutic potential of SGLT2 inhibitors and improve patient outcomes.
Dapagliflozin (SGLT2-inhibitors), classified under Anti-diabetics
Anti-diabetics, belonging to the pharmaceutical API (Active Pharmaceutical Ingredient) category, are a group of compounds designed to manage and treat diabetes mellitus, a chronic metabolic disorder characterized by high blood sugar levels. These medications play a vital role in controlling diabetes and preventing complications associated with the disease.
Anti-diabetics encompass a wide range of drug classes, including biguanides, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, and glucagon-like peptide-1 (GLP-1) receptor agonists. Each class works through different mechanisms to regulate blood sugar levels and improve insulin sensitivity.
Biguanides, such as metformin, reduce glucose production by the liver and enhance insulin sensitivity in peripheral tissues. Sulfonylureas, like glipizide, stimulate insulin secretion from pancreatic beta cells. Thiazolidinediones, including pioglitazone, improve insulin sensitivity in muscle and adipose tissues. DPP-4 inhibitors, such as sitagliptin, increase insulin release and inhibit glucagon secretion. SGLT2 inhibitors, like dapagliflozin, decrease renal glucose reabsorption, leading to increased urinary glucose excretion. GLP-1 receptor agonists, such as exenatide, enhance insulin secretion, suppress glucagon release, slow gastric emptying, and promote satiety.
These anti-diabetic APIs serve as the foundational ingredients for the formulation of various oral tablets, capsules, and injectable medications used in the treatment of diabetes. By targeting different aspects of glucose regulation, they help patients achieve and maintain optimal blood sugar levels, thus reducing the risk of diabetic complications, such as cardiovascular disease, neuropathy, and nephropathy.
It is crucial for healthcare professionals to prescribe and administer these anti-diabetic medications appropriately, considering factors like the patient's medical history, co-existing conditions, and potential drug interactions. Regular monitoring of blood glucose levels and close medical supervision are necessary to ensure effective diabetes management.
In conclusion, anti-diabetics form a critical category of pharmaceutical APIs used for the treatment of diabetes. These compounds, encompassing various drug classes, work through distinct mechanisms to regulate blood sugar levels and improve insulin sensitivity. By facilitating glucose control, anti-diabetic APIs help mitigate the risk of complications associated with diabetes mellitus, ultimately promoting better health outcomes for patients.
Dapagliflozin API manufacturers & distributors
Compare qualified Dapagliflozin API suppliers worldwide. We currently have 31 companies offering Dapagliflozin API, with manufacturing taking place in 4 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| ALP PHARM | Producer | China | China | CoA, USDMF | 33 products |
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 229 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | CoA | 176 products |
| Biocon | Producer | India | India | CoA, USDMF | 36 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, KDMF, MSDS, USDMF, WC | 170 products |
| Dr. Sahu's Laboratories | Producer | India | India | CoA, GMP | 70 products |
| Emeishan Hongsen Biopharm... | Producer | China | China | CoA, MSDS | 107 products |
| Fuxing Long Rui Pharma | Producer | China | China | CoA, USDMF | 10 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Harman Finochem | Producer | India | India | CoA, USDMF | 34 products |
| Hikal | Producer | India | India | CoA, USDMF | 26 products |
| Honour Lab | Producer | India | India | CoA, USDMF | 30 products |
| Jiangsu Hansoh Pharma | Producer | China | China | CoA, USDMF | 10 products |
| Jiangxi Aifeimu Technolog... | Producer | China | China | CoA | 7 products |
| Kleem Pharmaceuticals | Producer | India | India | CoA | 22 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| Micro Labs | Producer | India | India | CoA, USDMF | 38 products |
| Morepen Laboratories Ltd. | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, ISO9001, MSDS, USDMF, WC | 22 products |
| MSN Labs. | Producer | India | India | CoA, GMP, USDMF, WC | 119 products |
| Piramal Pharma Solutions | Producer | India | India | CoA, USDMF | 44 products |
| Polpharma | Producer | Poland | Poland | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, JDMF, MSDS, USDMF | 64 products |
| Raks Pharma | Producer | India | India | CoA, USDMF | 58 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 157 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, USDMF | 762 products |
| Solfyn International LLP | Distributor | India | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WHO-GMP | 24 products |
| Sun Pharma | Producer | India | India | CoA, USDMF | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Valence Labs | Producer | India | India | CoA, GMP | 32 products |
| ZCL Chemicals | Producer | India | India | CoA, Other, FDA, ISO9001 | 30 products |
When sending a request, specify which Dapagliflozin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Dapagliflozin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
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