# FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas

> **NCT05913037** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.** · enrollment: 167 (actual)

## Conditions studied

- Neurofibromatosis 1
- Plexiform Neurofibroma
- NF1

## Interventions

- **DRUG:** Test group (Group A): FCN-159 8 mg, orally, once daily;
- **DRUG:** Control group (Group B): Placebo, orally, once daily;

## Key facts

- **NCT ID:** NCT05913037
- **Lead sponsor:** Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2023-06-20
- **Primary completion:** 2025-08-19
- **Final completion:** 2026-06-30
- **Target enrollment:** 167 (ACTUAL)
- **Last updated:** 2025-03-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05913037

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05913037, "FCN-159 in Adult Patients With Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT05913037. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
