Koselugo

(Selumetinib)

ApprovedSmall molecule

Selumetinib is used to treat certain types of cancer in children, specifically neurofibromatosis type 1-associated tumors. It works by slowing or stopping the growth of cancer cells.[2] Koselugo is currently approved and in use across 29 indications[4].[1]

Koselugo is one of 367 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

366

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Non-Small Cell Lung CancerUnknown status

NeurofibromatosisTerminated

Rectum CancerApproved

Carcinoma of Liver and Intrahepatic Biliary TractApproved

Kaposi's SarcomaTerminated

Adult Hepatocellular CarcinomaApproved

Pilocytic AstrocytomaApproved

Gastric AdenocarcinomaApproved

Cutaneous MelanomaApproved

Optic Nerve GlioblastomaApproved

Non-Small Cell Lung CancerPhase 2

Unknown status

NeurofibromatosisPhase 2

Terminated

Rectum CancerApproved

Approved

Carcinoma of Liver and Intrahepatic Biliary TractApproved

Approved

Kaposi's SarcomaApproved

Terminated

Adult Hepatocellular CarcinomaApproved

Approved

Pilocytic AstrocytomaApproved

Approved

Gastric AdenocarcinomaApproved

Approved

Cutaneous MelanomaApproved

Approved

Optic Nerve GlioblastomaApproved

Approved

Showing 10 of 29 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Koselugo

AstraZeneca

Approved

2 2

Zolymbus

AbbVie

Preclinical

1 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Spravato

WWim Janssens

Preclinical

2 5

Acupan

YYonsei University

Preclinical

1 6

Chantix

PPrism Pharmaceuticals

Preclinical

1 7

Nubain

AAultman Health Foundation

Preclinical

1 8

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 9

Paracetamol

GSK

Preclinical

1 10

Systemic Therapy

Bristol-Myers Squibb

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Low Grade Astrocytoma

NCT04576117

Phase 2Not yet recruiting

Neurofibromatosis

NCT06621082

Phase 2Not yet recruiting

Neurofibromatosis

NCT06620354

Phase 3Active, not recruiting

Metastatic Non Small Cell Lung Cancer

NCT01933932

Q1 2027

Phase 2Active, not recruiting

Advanced Malignant Solid Neoplasm

NCT03155620

Phase 1/2Active, not recruiting

Low Grade Glioma

NCT01089101

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer6 trials

Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01809210·55 enrolled

MEDI4736 With Selumetinib for KRAS Mutant Non-Small Cell Lung Cancer (NSCLC)

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT03004105

Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer

Unknown status·TThe Netherlands Cancer Institute·Phase 1/2·NCT02450656·320 enrolled

Show 3 more trials

National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer

Active, not recruiting·UUniversity of Birmingham·Phase 2·NCT02664935·423 enrolled

Selumetinib and Paclitaxel as Second-Line Treatment in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer

Completed·OOHSU Knight Cancer Institute·Phase 1·NCT02503358·23 enrolled

A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

Active, not recruiting·DDana-Farber Cancer Institute·Phase 2·NCT03392246·25 enrolled

Tics4 trials

To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Renal Impaired Subjects and Healthy Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02063204·24 enrolled

To Assess the Effect of Rifampicin on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02046850·24 enrolled

To Assess the Effect of Itraconazole and Fluconazole on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02093728·26 enrolled

Show 1 more trial

To Assess the Effect of Food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01974349·39 enrolled

Neurofibromatosis3 trials

The Clinical Study of the Treatment of Patients With Type I Neurofibromatosis With Smetinib Hydrosulfate Capsule

Not yet recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT06621082·19 enrolled

Clinical Study on the Treatment of Type I Neurofibromatosis With Smeitinib Hydrosulfate Capsule

Not yet recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT06620354·33 enrolled

Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors

Terminated·—·Phase 2·NCT03095248·10 enrolled

Thyroid Cancer3 trials

Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer

Terminated· AstraZeneca logo

AstraZeneca·Phase 3·NCT01843062·233 enrolled

Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer

Completed·—·Phase 2·NCT02393690·60 enrolled

Selumetinib in Treating Patients With Papillary Thyroid Cancer That Did Not Respond to Radioactive Iodine

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00559949·39 enrolled

Plexiform Neurofibroma3 trials

Selumetinib for the Prevention of Plexiform Neurofibroma Growth in NF Type 1

Recruiting·UUniversity of Alabama at Birmingham·Phase 2·NCT06188741·200 enrolled

Low-dose Selumetinib for the Treatment of Plexiform Neurofibromas in Chinese Children

Not yet recruiting·WWest China Hospital·Phase 2·NCT06763315·50 enrolled

Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04924608·145 enrolled

56 more indications

Metastatic NSCLC2 trials

SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients

Completed·UUNICANCER·Phase 2·NCT02117167·999 enrolled

Study of Selumetinib in Patients With Previously Treated or Untreated Advanced/Metastatic NSCLC

Completed·CCanadian Cancer Trials Group·Phase 1·NCT01783197·39 enrolled

Low Grade Glioma2 trials

Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1/2·NCT01089101·217 enrolled

A Phase 3 Randomized Study of Selumetinib Versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT03871257·165 enrolled

Breast Cancer2 trials

Fulvestrant With or Without AZD6244 in Treating Patients With Advanced Breast Cancer That Progressed After Aromatase Inhibitor Therapy

Completed·SSwiss Cancer Institute·Phase 2·NCT01160718·46 enrolled

SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer

Active, not recruiting·UUNICANCER·Phase 2·NCT02299999·1,460 enrolled

Pancreatic Cancer2 trials

Selumetinib and Erlotinib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01222689·46 enrolled

Selumetinib and Akt Inhibitor MK2206 or mFOLFOX Therapy Comprising Oxaliplatin and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer Previously Treated With Chemotherapy

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01658943·137 enrolled

Metastatic Melanoma2 trials

Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01143402·120 enrolled

Phase I Study of the Combination of the VEGFR Inhibitor, AZD2171, and MEK Inhibitor, AZD6244, in the Treatment of Solid Malignancies

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT01364051·19 enrolled

Advanced/Metastatic Solid Tumors2 trials

Study of MK-8353 + Selumetinib in Advanced/Metastatic Solid Tumors (MK-8353-014)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT03745989·30 enrolled

Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (MK-5618-001)

Terminated· Merck & Co. logo

Merck & Co.·Phase 1·NCT03833427·32 enrolled

Uveal Melanoma2 trials

Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01974752·152 enrolled

Intermittent Selumetinib for Uveal Melanoma

Completed·SShaheer A. Khan·Phase 1·NCT02768766·42 enrolled

Melanoma2 trials

Selumetinib and Akt Inhibitor MK2206 in Treating Patients With Stage III or Stage IV Melanoma Who Failed Prior Therapy With Vemurafenib or Dabrafenib

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01519427·2 enrolled

MEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV Melanoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00866177·167 enrolled

Neurofibromatosis Type 12 trials

An Intermediate Access Protocol for Selumetinib for Treatment of Neurofibromatosis Type 1

Approved for marketing· AstraZeneca logo

AstraZeneca··NCT03259633

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

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT05101148·24 enrolled

Advanced Malignant Solid Neoplasm2 trials

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05564377·2,900 enrolled

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03155620·1,377 enrolled

Low Grade Astrocytoma2 trials

A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)

Recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT04166409·170 enrolled

A Phase 3 Study of Selumetinib (NSC# 748727) or Selumetinib in Combination With Vinblastine for Non-NF1, Non-TSC Patients With Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT04576117·300 enrolled

Neurofibromatosis 12 trials

A Phase 1/1b/2 Study of Cabozantinib in Combination With Selumetinib for Plexiform Neurofibroma in Adults and Adolescents With Neurofibromatosis Type 1

Recruiting·GGirish Dhall, MD·Phase 1·NCT06502171·30 enrolled

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)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT04590235·32 enrolled

Double-blind1 trial

Selumetinib in Chinese Paediatric With Post-operative NF1-PNs, PhaseⅡ, Double-Blinded, Placebo-Controlled Study

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 2·NCT05825365

Advanced Solid Tumours1 trial

A Study to Assess the Safety, Tolerability and Anti-tumour Activity of Ascending Doses of Selumetinib in Combination With MEDI4736 and Selumetinib in Combination With MEDI4736 and Tremelimumab in Patients With Advanced Solid Tumours

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02586987·58 enrolled

Lung Cancer1 trial

Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT03944772·247 enrolled

Phase 11 trial

Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT01949870·6 enrolled

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01217450·33 enrolled

Biliary Cancer1 trial

Selumetinib in Treating Patients With Biliary Cancer That Cannot Be Removed By Surgery

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00553332·29 enrolled

Gefitinib1 trial

Selumetinib in Combination With Gefitinib in NSCLC Patients

Completed·NNational Taiwan University Hospital·Phase 1/2·NCT02025114·34 enrolled

Phase 21 trial

AMTEC IIT: Phase 2 Multiarm Study in TNBC

Terminated·—·Phase 2·NCT03801369·24 enrolled

Biliary Tract Cancer1 trial

ABC-04 a Study of Cisplatin, Gemcitabine and Selumetinib in Patients With Advanced Biliary Tract Cancer

Completed·UUniversity College, London·Phase 1·NCT01242605·13 enrolled

Tic Disorder1 trial

Selumetinib Sulfate in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03213691·21 enrolled

Bile Duct Cancer1 trial

Selumetinib and Akt Inhibitor MK-2206 in Treating Patients With Refractory or Advanced Gallbladder or Bile Duct Cancer That Cannot Be Removed By Surgery

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT01859182

Soft Tissue Sarcoma1 trial

Selumetinib With or Without Temsirolimus in Treating Patients With Metastatic, Recurrent, or Locally Advanced Soft Tissue Sarcoma That Cannot Be Removed By Surgery

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01206140·70 enrolled

Liver Cancer1 trial

Selumetinib in Treating Patients With Locally Advanced or Metastatic Liver Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00604721·19 enrolled

Unresectable1 trial

Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01166126·4 enrolled

Bladder Cancer1 trial

Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT02546661·117 enrolled

Acute Myeloid Leukemia1 trial

Selumetinib in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00588809·47 enrolled

Hepatic Impairment1 trial

To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02063230·32 enrolled

Endometrial Cancer1 trial

Selumetinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01011933·54 enrolled

Multiple Myeloma1 trial

AZD6244 (Selumetinib) in Treating Patients With Multiple Myeloma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01085214·37 enrolled

Non-squamous NSCLC1 trial

Selumetinib in Patients Receiving Pemetrexed and Platinum-based Chemotherapy in Advanced or Metastatic KRAS Wildtype or Unknown Non-Squamous NSCLC

Completed·CCanadian Cancer Trials Group·Phase 2·NCT02337530·62 enrolled

Single Dose1 trial

Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01931761·6 enrolled

Peritoneum Cancer1 trial

Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00551070·52 enrolled

Small Cell Lung Cancer1 trial

Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01750281·212 enrolled

NF11 trial

Selumetinib Paediatric NF1 Japan Study

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04495127·12 enrolled

Kaposi's sarcoma1 trial

A Study of Selumetinib in Patients With Kaposi's Sarcoma

Terminated·SSheffield Teaching Hospitals NHS Foundation Trust·Phase 1/2·NCT01752569·19 enrolled

Solid Tumors1 trial

Selumetinib and Olaparib in Solid Tumors

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT03162627·90 enrolled

Metastatic Colorectal Cancer1 trial

Selumetinib and Cyclosporine in Treating Patients With Advanced Solid Tumors or Advanced or Metastatic Colorectal Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02188264·40 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Selumetinib in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01278615·16 enrolled

Blood Cancer1 trial

Selumetinib and Azacitidine in High Risk Chronic Blood Cancers

Recruiting·UUniversity of Chicago·Phase 1·NCT03326310·18 enrolled

ESS1 trial

Dose-escalation Study to Assess Selumetinib Safety, Tolerability and PK

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01960374·117 enrolled

Cancers1 trial

Selumetinib in Cancers With BRAF Mutations

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00888134·28 enrolled

Oral1 trial

To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02056392·54 enrolled

Advanced Solid Malignancies1 trial

Selumetinib and Cixutumumab in Treating Patients With Advanced Solid Malignancies

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01061749·30 enrolled

Acute Lymphoblastic Leukaemia1 trial

International Trial of Selumetinib in Combination With Dexamethasone for the Treatment of Acute Lymphoblastic Leukaemia

Terminated·UUniversity of Birmingham·Phase 1/2·NCT03705507·12 enrolled

Neurofibromatosis 1 (NF1)1 trial

Phase II Trial of the MEK1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02407405·36 enrolled

Recurrent Endometrial Carcinoma1 trial

A Randomized Trial of Selumetinib and Olaparib or Selumetinib Alone in Patients With Recurrent or Persistent RAS Pathway Mutant Ovarian and Endometrial Cancers: A ComboMATCH Treatment Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05554328·165 enrolled

Recurrent Lung Non-Small Cell Carcinoma1 trial

Phase I/II Trial Immunotherapy With Durvalumab and Tremelimumab With Continuous or Intermittent MEK Inhibitor Selumetinib in NSCLC

Completed·MM.D. Anderson Cancer Center·Preclinical·NCT03581487·40 enrolled

Malignant Peripheral Nerve Sheath Tumor (MPNST)1 trial

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

Recruiting·AAeRang Kim·Preclinical·NCT06735820·45 enrolled

Metastatic Non Small Cell Lung Cancer1 trial

A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, in Patients Receiving Second Line Treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT 1)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT01933932·510 enrolled

Neurofibromatosis Type 21 trial

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

Not yet recruiting·BBeijing Tiantan Hospital·Phase 2·NCT07707947·20 enrolled

Pediatric Cancer1 trial

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Preclinical·NCT02813135·472 enrolled

Biliary Tract Carcinoma1 trial

A Randomized Phase II Trial of MEK Inhibitor Selumetinib (AZD6244) Combined Continuously or Sequentially With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Patients With Advanced Biliary Cancer

Active, not recruiting·UUniversity Health Network, Toronto·Phase 2·NCT02151084·57 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 10, 2020

KOSELUGO

NDA NDA213756

Sep 10, 2025

KOSELUGO

NDA NDA219943

Sources

References

[1]
ClinicalTrials.gov — 87 trial records for Selumetinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Koselugo drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Selumetinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Selumetinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA219943). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Koselugo. U.S. Food & Drug Administration.
[7]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dual Specificity Mitogen-Activated Protein Kinase Kinase 2 Inhibitor; Dual Specificity Mitogen-Activated Protein Kinase Kinase; MEK1/2 Inhibitor; Dual Specificity Mitogen-Activated Protein Kinase Kinase 1 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AstraZeneca

Patent Landscape[6]

Patent Cliff

Dec 12, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8178693Mar 13, 2026

9156795Dec 12, 2026

9562017Dec 12, 2026

7425637Mar 13, 2028

11813246Mar 26, 2029

3 more patents

12364684Mar 26, 2029

12318367Mar 26, 2029

12220403Mar 26, 2029

Koselugo

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer6 trials

Tics4 trials

Neurofibromatosis3 trials

Thyroid Cancer3 trials

Plexiform Neurofibroma3 trials

Metastatic NSCLC2 trials

Low Grade Glioma2 trials

Breast Cancer2 trials

Pancreatic Cancer2 trials

Metastatic Melanoma2 trials

Advanced/Metastatic Solid Tumors2 trials

Uveal Melanoma2 trials

Melanoma2 trials

Neurofibromatosis Type 12 trials

Advanced Malignant Solid Neoplasm2 trials

Low Grade Astrocytoma2 trials

Neurofibromatosis 12 trials

Double-blind1 trial

Advanced Solid Tumours1 trial

Lung Cancer1 trial

Phase 11 trial

Malignant Peripheral Nerve Sheath Tumor1 trial

Tumour1 trial

Refractory Solid Tumors1 trial

Biliary Cancer1 trial

Gefitinib1 trial

Phase 21 trial

Biliary Tract Cancer1 trial

Tic Disorder1 trial

Bile Duct Cancer1 trial

Soft Tissue Sarcoma1 trial

Liver Cancer1 trial

Unresectable1 trial

Bladder Cancer1 trial

Acute Myeloid Leukemia1 trial

Hepatic Impairment1 trial

Endometrial Cancer1 trial

Multiple Myeloma1 trial

Non-squamous NSCLC1 trial

Single Dose1 trial

Peritoneum Cancer1 trial

Small Cell Lung Cancer1 trial

NF11 trial

Kaposi's sarcoma1 trial

Solid Tumors1 trial

Metastatic Colorectal Cancer1 trial

Diffuse Large B-Cell Lymphoma1 trial

Blood Cancer1 trial

ESS1 trial

Cancers1 trial

Oral1 trial

Advanced Solid Malignancies1 trial

Acute Lymphoblastic Leukaemia1 trial

Neurofibromatosis 1 (NF1)1 trial

Recurrent Endometrial Carcinoma1 trial

Recurrent Lung Non-Small Cell Carcinoma1 trial

Malignant Peripheral Nerve Sheath Tumor (MPNST)1 trial

Metastatic Non Small Cell Lung Cancer1 trial

Neurofibromatosis Type 21 trial

Pediatric Cancer1 trial

Biliary Tract Carcinoma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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