Craniopharyngioma is a rare, typically slow-growing epithelial tumor arising in the sellar/suprasellar region near the pituitary and hypothalamus. Despite histologic benignity, it can cause substantial neurologic and endocrine morbidity due to local mass effects.
Rhythm Pharmaceuticals announced expanded Phase 3 TRANSCEND trial data showing an 18.8% placebo-adjusted BMI reduction at 52 weeks for setmelanotide in acquired hypothalamic obesity, with FDA PDUFA goal date set for March 20, 2026.
The FDA is set to announce decisions in March 2026 on several drug applications, including label expansions for approved therapies and new drug candidates, with some making repeat approval attempts.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07342686 |
Hypothalamic-Stratified Nursing Pathway for Pediatric Craniopharyngioma |
COMPLETED | |
| NCT07316101 |
Clinical Trial of an Anti-Fog Drainage Device for Endoscopic Endonasal Sellar Region Tumor Surgery |
NOT_YET_RECRUITING | NA |
| NCT07301554 |
Food Preferences and Craniopharyngiomas |
NOT_YET_RECRUITING | |
| NCT07177482 |
ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Craniopharyngioma Patients |
RECRUITING | NA |
| NCT06874426 |
The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction |
RECRUITING | |
| NCT06801756 |
Craniopharyngioma and Pregnancies |
RECRUITING | |
| NCT06299891 |
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity |
RECRUITING | PHASE2 |
| NCT06217848 |
The Effect of GLP-1 Agonist in Patients With Hypothalamic Obesity: Prospective, Pilot Study |
RECRUITING | EARLY_PHASE1 |
| NCT05525273 |
Treatment of BRAF ( B-Rapidly Accelerated Fibrosarcoma) Mutated Papillary Craniopharyngioma |
RECRUITING | PHASE2 |
| NCT05465174 |
Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults |
RECRUITING | PHASE2 |
