Last reviewed · How we verify
Dapagliflozin Pill
Dapagliflozin Pill is a SGLT2 inhibitor Small molecule drug developed by Centro Universitario de Ciencias de la Salud, Mexico. It is currently in Phase 3 development for Type 2 diabetes mellitus, Heart failure with reduced ejection fraction, Chronic kidney disease. Also known as: Forxiga, Dapagliflozin.
Dapagliflozin inhibits sodium-glucose cotransporter 2 (SGLT2) in the kidney to increase urinary glucose excretion and lower blood glucose levels.
Dapagliflozin is a small molecule that inhibits the sodium/glucose cotransporter 2, a mechanism that is used to treat conditions such as type 2 diabetes. It is available in a 10mg tablet form and has been studied for its effects on weight loss in obese adults without diabetes.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Dapagliflozin Pill |
|---|---|
| Also known as | Forxiga, Dapagliflozin |
| Sponsor | Centro Universitario de Ciencias de la Salud, Mexico |
| Drug class | SGLT2 inhibitor |
| Target | SGLT2 (sodium-glucose cotransporter 2) |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
SGLT2 is responsible for reabsorbing filtered glucose in the proximal tubule of the kidney. By blocking this transporter, dapagliflozin prevents glucose reabsorption, allowing excess glucose to be excreted in the urine. This mechanism reduces blood glucose independently of insulin secretion and also promotes modest weight loss and blood pressure reduction through osmotic diuresis.
Approved indications
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
Common side effects
- Genital mycotic infections
- Urinary tract infections
- Polyuria
- Diabetic ketoacidosis
- Volume depletion
Key clinical trials
- Dapagliflozin in Active Lupus Nephritis (PHASE4)
- SGLT-2 and DPP-4 Inhibition, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.
- The Impact of Clinical Pharmacist Intervention and Dapagliflozin as Add-On Therapy in the Management of Type 2 Diabetes Mellitus. (NA)
- Triple Therapy in T1DM (PHASE2, PHASE3)
- The Effect of Dapagliflozin on Weight Loss in Obese Adults Without Diabetes (PHASE4)
- Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation (PHASE4)
- MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin (EARLY_PHASE1)
- Adolescent Type 1 Diabetes Treatment With SGLT2i for hyperglycEMia & hyPerfilTration Trial (PHASE3)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dapagliflozin Pill CI brief — competitive landscape report
- Dapagliflozin Pill updates RSS · CI watch RSS
- Centro Universitario de Ciencias de la Salud, Mexico portfolio CI
Frequently asked questions about Dapagliflozin Pill
What is Dapagliflozin Pill?
How does Dapagliflozin Pill work?
What is Dapagliflozin Pill used for?
Who makes Dapagliflozin Pill?
Is Dapagliflozin Pill also known as anything else?
What drug class is Dapagliflozin Pill in?
What development phase is Dapagliflozin Pill in?
What are the side effects of Dapagliflozin Pill?
What does Dapagliflozin Pill target?
Related
- Drug class: All SGLT2 inhibitor drugs
- Target: All drugs targeting SGLT2 (sodium-glucose cotransporter 2)
- Manufacturer: Centro Universitario de Ciencias de la Salud, Mexico — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
- Indication: Drugs for Heart failure with reduced ejection fraction
- Indication: Drugs for Chronic kidney disease
- Also known as: Forxiga, Dapagliflozin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing