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Farxiga (DAPAGLIFLOZIN)
Farxiga works by blocking the SGLT2 protein in the kidneys, reducing glucose reabsorption and promoting its excretion in the urine.
Farxiga (Dapagliflozin) is a small molecule Sodium-Glucose Cotransporter 2 (SGLT2) inhibitor developed by AstraZeneca AB. It works by blocking the SGLT2 protein in the kidneys, reducing glucose reabsorption and promoting its excretion in the urine. Farxiga is approved to treat chronic heart failure, chronic kidney disease, and diabetes mellitus types 1 and 2. It remains patented and has no generic manufacturers. Key safety considerations include the risk of dehydration and hypotension.
At a glance
| Generic name | DAPAGLIFLOZIN |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | Sodium-Glucose Cotransporter 2 Inhibitor |
| Target | Sodium/glucose cotransporter 2 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2014 |
| Annual revenue | 6300 |
Mechanism of action
Sodium-glucose cotransporter (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion. 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.
Approved indications
- Chronic heart failure
- Chronic kidney disease
- Diabetes mellitus type 1
- Diabetes mellitus type 2
Common side effects
- Female genital mycotic infections
- Nasopharyngitis
- Urinary tract infections
- Back pain
- Increased urination
- Nausea
- Influenza
- Dyslipidemia
- Constipation
- Discomfort with urination
- Pain in extremity
- Cystitis
Key clinical trials
- Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes (PHASE3)
- Dapagliflozin DPPIV Inhibitor add-on Study (PHASE3)
- Add-on to Thiazolidinedione (TZD) Failures (PHASE3)
- An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets (PHASE3)
- A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise (PHASE3)
- Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients (PHASE3)
- A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone (PHASE3)
- Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Farxiga CI brief — competitive landscape report
- Farxiga updates RSS · CI watch RSS
- AstraZeneca portfolio CI