← All organizations
Highest phase reached
Phase 3
First clinical trial
Oct 1, 2007First marketed drug
Aug 14, 2019First NDA
Aug 14, 2019Last known activity
Sep 15, 2025
Timeline
1980s
- Jan 1, 1981
Bioprojet— Founded
2010s
- Aug 14, 2019
pitolisant— NDA Organization
Drugs by trial phase (8 distinct, 30 trials)
Phase 3 (2 own, 0 via acquisition)
Phase 1 (4 own, 0 via acquisition)
Indications
Approved for
Studied for
- Alcohol Drinking
- Alcohol-Induced Disorders, Nervous System
- Alcoholism
- Apnea
- Behavior, Addictive
- Cataplexy
- Narcolepsy
- Parasomnias
- Parkinson Disease
- Psychomotor Agitation
- Renal Insufficiency
- Restless Legs Syndrome
- Schizophrenia
- Sleep Apnea, Obstructive
- Sleep Apnea Syndromes
- Sleepiness
- Sleep Wake Disorders
- Substance-Related Disorders
- Syndrome
Marketed drugs (1)
Recent trials (38)
- NCT07047404Lead sponsorPhase 2Sep 15, 2025
- NCT07074002Lead sponsorPhase 2Jul 31, 2025
- NCT05953389Lead sponsorPhase 2Oct 31, 2023
- NCT05240560Lead sponsorPhase 2Sep 30, 2022
- NCT05118906Lead sponsorPhase 2Dec 31, 2021
- NCT03345953Lead sponsorPhase 2Feb 6, 2018
- NCT03424824Lead sponsorPhase 2Jan 9, 2018
- NCT03152123Lead sponsorPhase 1Mar 15, 2017
- NCT02978651Lead sponsorPhase 3Jan 1, 2017
- NCT02800083Lead sponsorPhase 2Oct 1, 2016
- NCT02929342Lead sponsorPhase 1Jul 1, 2016
- NCT02929342Study directorPhase 1Jul 1, 2016
- NCT02611687Lead sponsorPhase 2Apr 1, 2016
- NCT02739568Lead sponsorPhase 3Apr 1, 2016
- NCT01965301Lead sponsorPhase 1Oct 1, 2014
Details
- Founded
- Paris, FR Jan 1, 1981
- First NDA
- Aug 14, 2019
- Last known activity
- Sep 15, 2025
Designations held
- Orphan drug
- Fast track
- Priority review