selumetinib
selumetinib: sourced relationships with 2 companies · 12 clinical trials tracked · 2 FDA decisions.
selumetinib evidence translation
What we can confirm
2 FDA records · 12 tracked trials
What it means
What to watch
Prepared research question
What is verified about selumetinib, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence7 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| ARRAY BIOPHARMA INC (ARRY) cancer and NF1 | Phase 3 |
| ASTRAZENECA PLC (AZN) Reported 2020-04-10 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (12)showing 10 most recent
A Single-Center, Single-Arm, Phase II Study to Explore the Efficacy and Safety of MEK1/2 Inhibitor (MEKi) Selumetinib in the Treatment of Patients With NF2-Related Schwannomatosis
Primary endpoint: Objective Response Rate (ORR)in NF2-related vestibular schwannoma assessed according to the REiNS criteria
A Phase 1/1b/2 Study of Cabozantinib in Combination With Selumetinib for Plexiform Neurofibroma in Adults and Adolescents With Neurofibromatosis Type 1
Primary endpoint: The number of participants that experienced a dose limiting toxicity when taking cabozantinib and selumetinib together.
Early Phase Study to Evaluate the MEK Inhibitor Selumetinib With the MDM2 Inhibitor APG-115 in Patients With Neurofibromatosis Type 1 and Pre-malignant and Malignant Peripheral Nerve Sheath Tumors
Primary endpoint: The number of treated patients with adverse events as determined by the common criteria for adverse version 5 (CTCAEv5).
A Phase III, Multicentre, International Study With a Parallel, Randomised, Double-blind, Placebo-controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas (KOMET)
Primary endpoint: Confirmed Partial and Complete Response Rate (ORR) by End of Cycle 16 Using Volumetric MRI Analysis as Determined by ICR (Per REiNS Criteria) in Participants With NF1 Who Have Symptomatic, Inoperable PN.
A Phase I, Single-Arm, Sequential Study to Evaluate the Effect of Food on the Gastrointestinal Tolerability and Pharmacokinetics of Selumetinib After Multiple Doses in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas
Primary endpoint: Selumetinib area under the plasma concentration-time curve from zero to 12 hours post-dose (AUC0-12)
A Phase 1 Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Selumetinib, a Selective Mitogen Activated Protein Kinase Kinase (MEK) 1 Inhibitor, in Chinese Paediatric and Adult Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)
Primary endpoint: Adverse events
SARC031: A Phase 2 Trial of the MEK Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Combination With the mTOR Inhibitor Sirolimus for Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumors
Primary endpoint: Clinical Benefit Rate of Selumetinib in Combination With Sirolimus in Patients With Unresectable or Metastatic NF1 Associated or Sporadic MPNST.
A Phase II, Open-Label, Study of Olaparib in Combination With Either Durvalumab (MEDI4736), Selumetinib or Capivasertib, or Ceralasertib Monotherapy in Patients With Metastatic Triple-Negative Breast Cancer
Primary endpoint: Objective Response Rate (ORR)
Evaluation of the Combination of Selumetinib and Olaparib in Endometrial, Ovarian and Other Solid Tumors With Ras Pathway Alterations, and Ovarian Tumors With PARP Resistance
Primary endpoint: Maximum Tolerated Dose (MTD) for Combination of Selumetinib and Olaparib in Participants with Advanced or Recurrent Solid Tumors
An Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Multi-Centre, Multi-arm Phase 1b Study in Patients With Muscle Invasive Bladder Cancer (MIBC) Who Have Progressed on Prior Treatment (BISCAY).
Primary endpoint: Module A: The frequency and nature of adverse events related to AZD4547 monotherapy.
FDA Decisions2 records
Frequently asked questions
Which companies have sourced relationships with selumetinib?
selumetinib has dated SEC/FDA relationship records for ARRAY BIOPHARMA INC, ASTRAZENECA PLC.
How many clinical trials involve selumetinib?
BioSniper tracks 12 clinical trials involving selumetinib.
What is selumetinib's latest FDA decision?
The most recent tracked FDA decision for selumetinib is Approval for 1 INDICATIONS AND USAGE KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ]. KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). ( 1 ), dated September 10, 2025.