NCT06188741 (NF114) is a Phase 2 clinical trial of Selumetinib in Neurofibromatosis 1, sponsored by University of Alabama at Birmingham.

Who is sponsoring NCT06188741?

NCT06188741 is sponsored by University of Alabama at Birmingham.

What drugs are being tested in NCT06188741?

Interventions in NCT06188741: Selumetinib.

What condition does NCT06188741 study?

NCT06188741 studies Neurofibromatosis 1, Plexiform Neurofibroma.

Is NCT06188741 still recruiting?

NCT06188741 is currently recruiting now. Last updated 12 March 2026.

Last reviewed 2026-03-12 · How we verify

NCT06188741: NF114

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 2 Last updated 12 March 2026

What this trial tests

Phase 2 trial testing Selumetinib in Neurofibromatosis 1 in 200 participants. Currently enrolling.

Timeline

27 August 2025

Primary endpoint
1 September 2031

1 September 2032

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	27 August 2025
Primary completion	1 September 2031
Estimated completion	1 September 2032
Sites	13 locations across United States

Drugs / interventions tested

Selumetinib — full drug profile →

Conditions studied

Neurofibromatosis 1 — all drugs for Neurofibromatosis 1 →
Plexiform Neurofibroma — all drugs for Plexiform Neurofibroma →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 1 to 8, any sex, with Neurofibromatosis 1 or Plexiform Neurofibroma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Plexiform neurofibromas (PN) are known to cause significant morbidity in children with NF1. The recent FDA approval for selumetinib in children 2 years and older with inoperable symptomatic PN was based on the finding that selumetinib shrinks the majority of PN in children with NF1 and results in clinically meaningful benefit such as improvement in pain or range of motion. However, many morbidities, such as blindness or nerve damage, cannot be fully reversed with PN shrinkage. Therefore, there remains a critical need in this patient population to determine if young participants with PN in high-risk locations may benefit from early medical intervention prior to the development of clinical problems. This study will determine whether participants with asymptomatic PN in high-risk locations can potentially benefit from early treatment with selumetinib.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Update on Pediatric Cancer Surveillance Recommendations for Patients with Neurofibromatosis Type 1, Noonan Syndrome, CBL Syndrome, Costello Syndrome, and Related RASopathies.
Perrino MR, Das A, Scollon SR, Mitchell SG, et al · · 2024 · cited 14× · PMID 39196581 · DOI 10.1158/1078-0432.ccr-24-1611
MEK inhibitors for neurofibromatosis type 1-associated central and peripheral nervous system tumors.
Kotch C, de Blank P, Fangusaro J, Fisher MJ. · · 2026 · PMID 42059002 · DOI 10.1093/noajnl/vdae223
Neurofibromatosis type 1-plexiform neurofibromas: Integrating treatment across pediatric and adult populations.
Armstrong AE, Gross AM, Klesse LJ, Rhodes SD, et al · · 2026 · PMID 41645458 · DOI 10.1093/neuonc/noag023

Verify or expand the search:

Other trials of Selumetinib

Trials testing the same drug.

NCT06735820 — Early Phase Study Evaluating MEK and MDM2 Inhibition in Patients With NF1 and MPNST · Phase 1, PHASE2 · not yet recruiting
NCT06763315 — Low-dose Selumetinib for the Treatment of Plexiform Neurofibromas in Chinese Children · Phase 2 · not yet recruiting
NCT06621082 — The Clinical Study of the Treatment of Patients With Type I Neurofibromatosis With Smetinib Hydrosulfate Capsule · Phase 2 · not yet recruiting
NCT06620354 — Clinical Study on the Treatment of Type I Neurofibromatosis With Smeitinib Hydrosulfate Capsule · Phase 2 · not yet recruiting
NCT05825365 — Selumetinib in Chinese Paediatric With Post-operative NF1-PNs, PhaseⅡ, Double-Blinded, Placebo-Controlled Study · Phase 2 · withdrawn

Other recruiting trials for Neurofibromatosis 1

Currently open trials in the same condition.

NCT07233408 — Tailoring an Online Platform to Promote Evidence-Based Care for Adults With Neurofibromatosis 1 and Low Health Literacy · NA · recruiting
NCT06222203 — Surveillance for Malignant Transformation of Neurofibromatosis Type 1 (NF1) Related Peripheral Nerve Sheath Tumors (PNST · recruiting
NCT06360406 — Real-World Treatment Study of Koselugo (Selumetinib) · recruiting
NCT05361811 — Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and F · NA · recruiting
NCT05913037 — FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas · Phase 3 · active not recruiting

Other University of Alabama at Birmingham trials

Trials by the same sponsor.

NCT04922229 — Comparative Effectiveness in the Management of Irreversible Pulpitis · NA · not yet recruiting
NCT05060380 — Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis · NA · withdrawn
NCT04768777 — Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis · NA · not yet recruiting
NCT06320951 — VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine · Phase 2 · not yet recruiting
NCT07564934 — Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilit · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06188741 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
Last refreshed: 12 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06188741.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing