Product Description
a novel MEK inhibitor, for the treatment of plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1). (Sourced from: https://pubmed.ncbi.nlm.nih.gov/34541874/)
Mechanisms of Action: MAP2K Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Brazil | Croatia | Czech | Estonia | European Medicines Agency | Finland | France | Germany | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Malaysia | Mexico | Netherlands | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Arab Emirates | United Kingdom | United States
Approved Indications: Fibroma | Neurofibroma
Known Adverse Events: Abdominal Pain | Pain Unspecified | Stomatitis | Pruritus | Paronychia | Musculoskeletal Pain | Acute Lymphoid Leukemia | Diarrhea
Company: AstraZeneca
Company Location: CAMBRIDGE X0 CB2 0AA
Company CEO: Pascal Soriot
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Netherlands, Poland, Puerto Rico, Russia, Spain, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 27
Highest Development Phases
Phase 3: Neurofibroma, Plexiform|Neurofibromatoses|Neurofibromatosis 1
Phase 2: Adenocarcinoma|Endometrial Cancer|Ependymoma|Glioma|Meningioma|Neurilemmoma|Neurofibromatosis 2|Neurofibrosarcoma|Neuroma, Acoustic|Non-Small-Cell Lung Cancer|Optic Nerve Glioma|Ovarian Cancer|Pancreatic Cancer|Peritoneal Cancer|Triple Negative Breast Cancer
Phase 1: Breast Cancer|Neurofibroma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| Selumetinib for children with Nervous System Tumors | P1 |
Active, not recruiting |
Neurofibroma |
2032-03-03 |
|
| NF114 | P2 |
Not yet recruiting |
Neurofibroma, Plexiform|Neurofibromatosis 1|Neurofibromatoses |
2030-12-01 |
|
| NCI-2022-06841 | P2 |
Recruiting |
Ovarian Cancer|Peritoneal Cancer|Endometrial Cancer |
2028-10-01 |
|
| D1346C00015 | P1 |
Unknown Status |
Neurofibroma, Plexiform |
2028-06-30 |