Product Description
Pfizer is developing Reboxetine as a treatment for narcolepsy. (Sourced from: https://www.pfizer.com/news/press-release/press-release-detail/axsome-therapeutics-enters-exclusive-license-agreement)
Mechanisms of Action: NaR Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral, Vaginal
FDA Designation: Breakthrough Therapy - Narcolepsy *
Approval Status: Not Approved
Approved Countries: Australia | Austria | Belgium | Brazil | Bulgaria | Chile | Croatia | Denmark | Egypt | Germany | Hungary | Iceland | India | Ireland | Israel | Italy | Luxembourg | New Zealand | Norway | Peru | Poland | Portugal | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | United Kingdom | Venezuela
Approved Indications: None
Known Adverse Events: None
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Axsome announced they will present P3 Narcolepsy results in 2H24 for Reboxetine
Highest Development Phases
Phase 3: Cataplexy|Disorders of Excessive Somnolence|Narcolepsy
Phase 2: Sleep Apnea, Obstructive
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2023-000062-34 |
2023-000062-34 | P2 |
Completed |
Sleep Apnea, Obstructive |
2024-12-04 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT05113745 |
ENCORE | P3 |
Completed |
Disorders of Excessive Somnolence|Narcolepsy|Cataplexy |
2024-11-15 |
30% |
2025-11-14 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT05059223 |
SYMPHONY | P3 |
Completed |
Disorders of Excessive Somnolence|Cataplexy|Narcolepsy |
2024-03-15 |
24% |
2024-04-23 |