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Simdax
Simdax is a Small molecule drug developed by Yooyoung Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Congestive heart failure.
Simdax, also known as levosimendan, is a small molecule drug that inhibits phosphodiesterase 3, a calcium sensitizer used in the management of acutely decompensated congestive heart failure. It has been studied for various conditions including muscle weakness, weaning failure, heart failure, myocardial stunning, and cardiorenal syndrome.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | Simdax |
|---|---|
| Sponsor | Yooyoung Pharmaceutical Co., Ltd. |
| Target | ATP-sensitive inward rectifier potassium channel 8, ATP-sensitive inward rectifier potassium channel 11, Troponin C, slow skeletal and cardiac muscles |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Approved indications
- Congestive heart failure
Common side effects
Key clinical trials
- Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease? (PHASE2)
- Evaluate the Efficacy and Safety of Short-term Administration of SIMDAX (PHASE3)
- Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery (PHASE4)
- Spanish Randomized Clinical Trial to Compare Levosimendan Versus Placebo in Postoperative Cardiac Surgery (SPARTANS) (PHASE2, PHASE3)
- Levosimendan In Patients Undergoing LVAD Implantation
- Levosimendan Versus Dobutamine for Renal Function in Heart Failure (PHASE3)
- Preoperative levosimendán and Hip Fracture
- Intracoronary Administration of Levosimendan in Cardiac Surgery Patients (PHASE4)
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:
- Simdax CI brief — competitive landscape report
- Simdax updates RSS · CI watch RSS
- Yooyoung Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Simdax
What is Simdax?
What is Simdax used for?
Who makes Simdax?
What development phase is Simdax in?
What does Simdax target?
Related
- Target: All drugs targeting ATP-sensitive inward rectifier potassium channel 8, ATP-sensitive inward rectifier potassium channel 11, Troponin C, slow skeletal and cardiac muscles
- Manufacturer: Yooyoung Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Congestive heart failure
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing