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Dapaglifozin
Dapaglifozin is a Small molecule drug developed by MedImmune LLC. It is currently in Phase 3 development for Chronic heart failure, Chronic kidney disease, Diabetes mellitus type 1.
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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 | Dapaglifozin |
|---|---|
| Sponsor | MedImmune LLC |
| Target | Low affinity sodium-glucose cotransporter, Sodium/myo-inositol cotransporter 2, Sodium/glucose cotransporter 1 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | Phase 3 |
Approved indications
- Chronic heart failure
- Chronic kidney disease
- Diabetes mellitus type 1
- Diabetes mellitus type 2
Common side effects
- Viral upper respiratory tract infection
- Tachycardia
- Diarrhoea
- Nausea
- Hyperhidrosis
- Headache
- Tachycardia paroxysmal
- Tinnitus
- Dyspepsia
- Gastroenteritis
- Genital infection fungal
- Oral herpes
Key clinical trials
- Assessing the Efficacy of Dapagliflozin as a Vasculoprotective Treatment in Septic Shock Patients With Microcirculatory Dysfunction (PHASE3)
- Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy (NA)
- Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure (PHASE4)
- Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D) (PHASE1)
- Effect of DAPAglifozin on MYOcardial Remodeling of Breast CANCER Patients Treated with Anthracycline Based Chemotherapy (PHASE3)
- Pilot Study to Explore the Efficacy of DAPAglifozin as add-on to Closed-loop Control in Patients With Type 1 Diabetes (PHASE1)
- DYNAMic Renal Assessment: NOvel Methods to Assess KIDNEY Functional Reserve
- MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin (EARLY_PHASE1)
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:
- Dapaglifozin CI brief — competitive landscape report
- Dapaglifozin updates RSS · CI watch RSS
- MedImmune LLC portfolio CI
Frequently asked questions about Dapaglifozin
What is Dapaglifozin?
What is Dapaglifozin used for?
Who makes Dapaglifozin?
What development phase is Dapaglifozin in?
What are the side effects of Dapaglifozin?
What does Dapaglifozin target?
Related
- Target: All drugs targeting Low affinity sodium-glucose cotransporter, Sodium/myo-inositol cotransporter 2, Sodium/glucose cotransporter 1
- Manufacturer: MedImmune LLC — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Chronic heart failure
- Indication: Drugs for Chronic kidney disease
- Indication: Drugs for Diabetes mellitus type 1
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing