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levosemindan
levosemindan is a Small molecule drug developed by Ain Shams University. It is currently in Phase 3 development.
Levosemindan is being studied as a potential treatment for conditions such as acute myocarditis, cardiac surgery complications, and low ejection fraction. It is being compared to other interventions like adrenaline, noreadrenaline, dopamine, and dobutamine in clinical trials.
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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 | levosemindan |
|---|---|
| Sponsor | Ain Shams University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- The Role of Levosimendan as Inotropic Agent in Acute Aluminum Phosphide-induced Cardiotoxicity (PHASE3)
- Impact of Perioperative Levosimendan on Patients Undergoing Cardiac Surgery With Low Ejection Fraction (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:
- levosemindan CI brief — competitive landscape report
- levosemindan updates RSS · CI watch RSS
- Ain Shams University portfolio CI
Frequently asked questions about levosemindan
What is levosemindan?
Who makes levosemindan?
What development phase is levosemindan in?
Related
- Manufacturer: Ain Shams University — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing