Product Description
for Sleep Disorders of Children With Neurodevelopmental Disorders; melatonin (Sourced from: https://clinicaltrials.gov/ct2/show/NCT02757079)
Mechanisms of Action: MT Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lithuania | Luxembourg | Malta | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Poland | Portugal | Romania | Russia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Nobelpharma
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Denmark, Japan, New Zealand, Spain
Active Clinical Trial Count: 8
Highest Development Phases
Phase 3: Chronic Pain|Emergence Delirium|Fetal Death|Fetal Growth Retardation|Insomnia|Low Back Pain|Obstetric Labor, Premature|Pregnancy Outcomes|Stillbirth
Phase 2: Dementia|Multiple Sclerosis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| MEL-QUE | P3 |
Recruiting |
Insomnia |
2029-02-28 |
|
| MOCHA | P3 |
Recruiting |
Low Back Pain|Insomnia|Chronic Pain |
2026-10-15 |
|
| MELATOMS-1 | P2 |
Unknown Status |
Multiple Sclerosis |
2026-03-31 |
|
| PROTECTMe | P3 |
Recruiting |
Pregnancy Outcomes|Fetal Death|Stillbirth|Fetal Growth Retardation|Obstetric Labor, Premature |
2025-12-30 |