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Melatonin/experimental
Melatonin is a pineal hormone that acts as a circadian rhythm regulator and antioxidant to modulate sleep-wake cycles and reduce oxidative stress.
Melatonin is a pineal hormone that acts as a circadian rhythm regulator and antioxidant to modulate sleep-wake cycles and reduce oxidative stress. Used for Sleep disorders / Insomnia, Circadian rhythm disorders.
At a glance
| Generic name | Melatonin/experimental |
|---|---|
| Also known as | Melatona |
| Sponsor | Tehran University of Medical Sciences |
| Drug class | Circadian rhythm modulator / Antioxidant |
| Target | MT1 receptor, MT2 receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology / Sleep Medicine |
| Phase | Phase 3 |
Mechanism of action
Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus and other tissues to regulate circadian rhythms and promote sleep. Additionally, it functions as a free radical scavenger and antioxidant, reducing oxidative stress and inflammation in various tissues, which may provide neuroprotective and immunomodulatory benefits.
Approved indications
- Sleep disorders / Insomnia
- Circadian rhythm disorders
Common side effects
- Headache
- Dizziness
- Drowsiness
- Nausea
Key clinical trials
- The Effect of BWSTT on Neuroendocrine Profile and Functional Recovery in Stroke Patients (NA)
- Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction (NA)
- Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery (PHASE2)
- Melatonin & Metformin on Clinical & Biochemical Parameters in Insulin Resistant PCOS Compared to Metformin (NA)
- Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial (NA)
- Beneficial Effects of Daytime Light Exposure and Physical Activity on the Human Circadian Clock and Sleep (NA)
- Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients (PHASE3)
- A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Efficacy Study (EARLY_PHASE1)
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/experimental CI brief — competitive landscape report
- Melatonin/experimental updates RSS · CI watch RSS
- Tehran University of Medical Sciences portfolio CI