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Drugs in development · updated 30 October 2026

Melatonin: clinical trials and development status

Other names and codes: Slenyto, Circadin

NLM verified identityNot approved in the USAuthorised in the EU (EMA) since 29 June 2007Estimated launch Dec 2027 – Oct 2028 (Phuturdex estimate)

As of 30 October 2026 Melatonin is in 38 active clinical trials (recruiting or ongoing, phases I–III) for 44 diseases. The most advanced phase is III.

38Active trials
IIIMost advanced phase
44Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow Melatonin and get an email at every change or safety alert.

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Diseases studied

For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov. Showing 30 of 44 diseases.

DiseaseMost advanced phaseActive trialsReference trial
Anxiety disorderIII2NCT07336095
Emergence deliriumIII2NCT05541276
FatigueII–III2NCT05474846
Fetal Growth RetardationIII2NCT05651347
Mental disorderII–III2NCT06062953
Sleep Initiation and Maintenance DisordersII–III2NCT06062953
Acute kidney injuryIII1NCT05084196
Adverse drug reactionIII1NCT05084196
AnorexiaIII1NCT07576764
Anorexia nervosaIII1NCT07576764
Arterial hypertensionII–III1NCT06935292
CardiomyopathiesIII1NCT06846086
Central serous retinopathyII–III1NCT06809751
DepressionII–III1NCT05474846
Fetal deathIII1NCT05651347
InflammationII–III1NCT07721324
NeoplasmII–III1NCT05474846
Post-traumatic stress disorderIII1NCT07418554
Postoperative nausea and vomitingIII1NCT05541276
Postoperative painIII1NCT05541276
StillbirthIII1NCT05651347
Systemic lupus erythematosusII–III1NCT07721324
Uveal melanomaIII1NCT05502900
Bipolar disorderII2NCT07472075
Brain hypoxia-ischemiaII2NCT07305350
Bipolar and related disordersII1NCT07472075
Breast neoplasmI–II1NCT07067307
Circadian rhythm sleep disorderII1NCT06226025
Critical illnessII1NCT05713877
Crying outI–II1NCT07442162

Everything on Melatonin

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Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 30 October 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, is a Phuturdex calculation described on the Method page, not official data.

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