Clinical development

Our clinical development programs, designed in compliance with ethical and regulatory standards to address identified therapeutic needs, aim to demonstrate the safety, efficacy, and medical value of our drug candidates.

#BIOTECH

BIOPROJET
RESEARCH AND DEVELOPMENT

Most of the medicines developed by Bioprojet are « First in Class », meaning they are the leaders of new pharmacological classes :

RACECADOTRIL :

an enkephalinase inhibitor that has demonstrated intestinal antisecretory activity.

PITOLISANT :

an inverse agonist/antagonist of the histamine H3 receptor.

With an original mechanism of action, these new chemical entities have undergone a complete development process, covering the pharmaceutical, preclinical, and clinical phases, in order to obtain marketing authorization.

The Clinical Development Department, located in Paris, is responsible for advancing drug candidates originating from the Bioprojet Research Center by conducting human clinical trials from Phase I to Phase III, leading to the granting of Marketing Authorization (MA) for the targeted indications.

Pitolisant (inverse agonist/antagonist of the histamine H3 receptor)

Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
Treatment of excessive daytime sleepiness and cataplexy attacks in adult patients with narcolepsy
Treatment of excessive daytime sleepiness and cataplexy attacks in pediatric patients with narcolepsy
Treatment of excessive daytime sleepiness in patients with Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS)

BP1.4979 (Partial agonist of the dopamine D3 receptor)

Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
Binge eating disorder
Premature ejaculation
Essential tremor
Obsessive-compulsive disorder (OCD)

BP1.7881 (Mixed antagonist of histamine H4 and H1 receptors)

Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
Eosinophilic esophagitis

New formulation of adrenaline

Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
Anaphylaxis

BP1.15205 (Orexin receptor 2 agonist)

Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
Sleep and wakefulness disorders
Tous
  • Tous
  • Pitolisant (inverse agonist/antagonist of the histamine H3 receptor)
  • BP1.4979 (Partial agonist of the dopamine D3 receptor)
  • BP1.7881 (Mixed antagonist of histamine H4 and H1 receptors)
  • New formulation of adrenaline
  • BP1.15205 (Orexin receptor 2 agonist)
Pitolisant (inverse agonist/antagonist of the histamine H3 receptor)
Treatment of excessive daytime sleepiness and cataplexy attacks in adult patients with narcolepsy
Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
Treatment of excessive daytime sleepiness and cataplexy attacks in pediatric patients with narcolepsy
Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
Treatment of excessive daytime sleepiness in patients with Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS)
Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
BP1.4979 (Partial agonist of the dopamine D3 receptor)
Binge eating disorder
Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
Premature ejaculation
Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
Essential tremor
Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
Obsessive-compulsive disorder (OCD)
Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
BP1.7881 (Mixed antagonist of histamine H4 and H1 receptors)
Eosinophilic esophagitis
Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
New formulation of adrenaline
Anaphylaxis
Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV
BP1.15205 (Orexin receptor 2 agonist)
Sleep and wakefulness disorders
Preclinical
phase I
phase II
phase III
phase AMM - PHASE IV