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
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Canada, United States
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Cataplexy|Disorders of Excessive Somnolence|Narcolepsy
Phase 2: Sleep Apnea, Obstructive
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| RENTOSA | P2 |
Recruiting |
Sleep Apnea, Obstructive |
2025-07-01 |
|
| 2023-000062-34 | P2 |
Active, not recruiting |
Sleep Apnea, Obstructive |
2025-04-11 |
|
| AXS-12-302 | P3 |
Enrolling by invitation |
Narcolepsy|Cataplexy|Disorders of Excessive Somnolence |
2024-12-01 |
90% |
| SYMPHONY | P3 |
Completed |
Cataplexy|Disorders of Excessive Somnolence|Narcolepsy |
2024-03-15 |
90% |