Last reviewed · How we verify
Empagliflozine
Empagliflozine is a Small molecule drug developed by Tel Aviv University. It is currently in Phase 1 development. Also known as: EMP.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Empagliflozine |
|---|---|
| Also known as | EMP |
| Sponsor | Tel Aviv University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Antithrombotic Activities of Sotagliflozin vs. Empagliflozin (PHASE4)
- Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)
- Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors
- SGLT2i Therapy in Islet Transplantation (SIT) (PHASE4)
- Post Marketing Surveillance of JARDIANCE in Chronic Kidney Disease
- A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension (PHASE1)
- A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart (PHASE3)
- SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism (PHASE2)
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:
- Empagliflozine CI brief — competitive landscape report
- Empagliflozine updates RSS · CI watch RSS
- Tel Aviv University portfolio CI
Frequently asked questions about Empagliflozine
What is Empagliflozine?
Who makes Empagliflozine?
Is Empagliflozine also known as anything else?
What development phase is Empagliflozine in?
Related
- Manufacturer: Tel Aviv University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: EMP
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing