Pitolisant

Phase 3Recruiting

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Interest: 41/100

Hype Score

Development Stage

✓

Pre-clinical

✓

Phase 1

✓

Phase 2

Phase 3

Approved

Indication / Disease

Prader-Willi Syndrome

Conditions

Prader-Willi Syndrome

Trial Timeline

Aug 20, 2025 → Aug 1, 2030

NCT ID

NCT07219485

About Pitolisant

Pitolisant is a phase 3 stage product being developed by Harmony Biosciences for Prader-Willi Syndrome. The current trial status is recruiting. This product is registered under clinical trial identifier NCT07219485. Target conditions include Prader-Willi Syndrome.

What happened to similar drugs?

0 of 8 similar drugs in Prader-Willi Syndrome were approved

Approved (0) Terminated (1) Active (7)

🔄somatropin - GH naïve pediatric cohort + somatropin - GH treated cohort + somatropin - adult cohortPfizerPhase 3

🔄CarbetocinAcadia PharmaceuticalsPhase 3

🔄Carbetocin + PlaceboAcadia PharmaceuticalsPhase 3

🔄DCCRSoleno TherapeuticsPhase 3

🔄DCCR + DCCR + Placebo for DCCRSoleno TherapeuticsPhase 3

🔄Pitolisant tabletHarmony BiosciencesPhase 3

❌DCCRSoleno TherapeuticsPhase 3

Hype Score Breakdown

Clinical

Activity

Company

Novelty

Community

Clinical Trials (4)

NCT ID	Phase	Status	Start	Completion	Indication
NCT03433131	Pre-clinical	Completed	—	—	Narcolepsy Without Cataplexy
NCT07219485	Phase 3	Recruiting	Aug 20, 2025	Aug 1, 2030	Prader-Willi Syndrome
NCT05581576	Approved	UNKNOWN	Sep 20, 2022	May 1, 2023	Restless Legs Syndrome
NCT05458128	Phase 3	Completed	Aug 19, 2022	Oct 1, 2025	Idiopathic Hypersomnia

Competing Products

18 competing products in Prader-Willi Syndrome

See all competitors

Product	Company	Stage	Hype Score
Octreotide + Placebo	Novartis	Pre-clinical	18
Norditropin SimpleXx	Novo Nordisk	Pre-clinical	26
somatropin - GH naïve pediatric cohort + somatropin - GH treated cohort + somatropin - adult cohort	Pfizer	Phase 3	40
Setmelanotide + Placebo	Rhythm Pharmaceuticals	Phase 2	32
Setmelanotide	Rhythm Pharmaceuticals	Phase 2	36
RGH-706 + Placebo	Richter Gedeon	Phase 2	32
Carbetocin	Acadia Pharmaceuticals	Phase 3	44
Carbetocin + Placebo	Acadia Pharmaceuticals	Phase 3	41
DCCR	Soleno Therapeutics	Phase 3	38
DCCR + DCCR + Placebo for DCCR	Soleno Therapeutics	Phase 3	34
Pitolisant tablet	Harmony Biosciences	Phase 3	41
Pitolisant oral tablets + Placebo oral tablet	Harmony Biosciences	Phase 2	33
DCCR	Soleno Therapeutics	Phase 3	26
VYKAT XR	Soleno Therapeutics	Pre-clinical	27
DCCR + Placebo for DCCR	Soleno Therapeutics	Phase 3	34
NNZ-2591	Neuren Pharmaceuticals	Phase 2	21
BMB-101 + Placebo	Bright Minds Biosciences	Phase 2	36
ARD-101	Aardvark Therapeutics	Phase 2	25