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Melatonin intravenous
Melatonin intravenous is a Small molecule drug developed by Pharmamel S.L.. It is currently in Phase 2 development.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Melatonin intravenous |
|---|---|
| Sponsor | Pharmamel S.L. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Sleep and Circadian Mechanisms in Hypertension (NA)
- EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES (PHASE2)
- Comparison Of The Effects Of Melatonin Premedication And Ketamine On Postoperative Sleep Quality İn Rhinoplasty (PHASE4)
- Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty (NA)
- MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children (PHASE3)
- Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium (NA)
- Observational Study on the Use of Ivermectin as an Outpatient Treatment Option for COVID-19
- Does Melatonin Affect Anesthetic MAC (Minimum Alveolar Concentration)? (NA)
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:
- Melatonin intravenous CI brief — competitive landscape report
- Melatonin intravenous updates RSS · CI watch RSS
- Pharmamel S.L. portfolio CI
Frequently asked questions about Melatonin intravenous
What is Melatonin intravenous?
Who makes Melatonin intravenous?
What development phase is Melatonin intravenous in?
Related
- Manufacturer: Pharmamel S.L. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing