Last reviewed 2026-04-23 · How we verify

pediatric, prolonged released melatonin

University Hospital, Strasbourg, France · Phase 3 active Small molecule

pediatric, prolonged released melatonin is a Melatonin receptor agonist Small molecule drug developed by University Hospital, Strasbourg, France. It is currently in Phase 3 development for Treatment of insomnia in pediatric patients.

Melatonin is a hormone that regulates sleep-wake cycles, and prolonged release formulations aim to maintain therapeutic levels throughout the night.

Melatonin is a hormone that regulates sleep-wake cycles, and prolonged release formulations aim to maintain therapeutic levels throughout the night. Used for Treatment of insomnia in pediatric patients.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	pediatric, prolonged released melatonin
Sponsor	University Hospital, Strasbourg, France
Drug class	Melatonin receptor agonist
Target	Melatonin receptor
Modality	Small molecule
Therapeutic area	Sleep disorders
Phase	Phase 3

Mechanism of action

Melatonin's mechanism of action primarily involves binding to melatonin receptors in the brain, which helps to induce sleepiness and reduce sleep latency. Prolonged release formulations are designed to provide a sustained release of melatonin, allowing for a more consistent and prolonged effect on sleep-wake cycles.

Approved indications

Treatment of insomnia in pediatric patients

Common side effects

Headache
Dizziness
Nausea

Key clinical trials

Sleep Disturbances in Children and Adolescents With Post-traumatic Stress Disorder (PTSD): a Randomized Double-blind Placebo-controlled Trial to Investigate the Efficacy of Pediatric Prolonged-release Melatonin (PHASE3)

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:

pediatric, prolonged released melatonin CI brief — competitive landscape report
pediatric, prolonged released melatonin updates RSS · CI watch RSS
University Hospital, Strasbourg, France portfolio CI

Frequently asked questions about pediatric, prolonged released melatonin

What is pediatric, prolonged released melatonin?

pediatric, prolonged released melatonin is a Melatonin receptor agonist drug developed by University Hospital, Strasbourg, France, indicated for Treatment of insomnia in pediatric patients.

How does pediatric, prolonged released melatonin work?

Melatonin is a hormone that regulates sleep-wake cycles, and prolonged release formulations aim to maintain therapeutic levels throughout the night.

What is pediatric, prolonged released melatonin used for?

pediatric, prolonged released melatonin is indicated for Treatment of insomnia in pediatric patients.

Who makes pediatric, prolonged released melatonin?

pediatric, prolonged released melatonin is developed by University Hospital, Strasbourg, France (see full University Hospital, Strasbourg, France pipeline at /company/university-hospital-strasbourg-france).

What drug class is pediatric, prolonged released melatonin in?

pediatric, prolonged released melatonin belongs to the Melatonin receptor agonist class. See all Melatonin receptor agonist drugs at /class/melatonin-receptor-agonist.

What development phase is pediatric, prolonged released melatonin in?

pediatric, prolonged released melatonin is in Phase 3.

What are the side effects of pediatric, prolonged released melatonin?

Common side effects of pediatric, prolonged released melatonin include Headache, Dizziness, Nausea.

What does pediatric, prolonged released melatonin target?

pediatric, prolonged released melatonin targets Melatonin receptor and is a Melatonin receptor agonist.

Drug class: All Melatonin receptor agonist drugs
Target: All drugs targeting Melatonin receptor
Manufacturer: University Hospital, Strasbourg, France — full pipeline
Therapeutic area: All drugs in Sleep disorders
Indication: Drugs for Treatment of insomnia in pediatric patients

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing