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"Neo-Bladder" Construct
Neo-Bladder Construct, marketed by Wake Forest University Health Sciences, is uniquely positioned as a single-agent treatment for BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. The key composition patent, set to expire in 2028, provides a strong barrier to entry for generic competitors. However, the lack of revenue data and key trial results poses a significant risk in assessing the drug's market performance and efficacy.
At a glance
| Generic name | "Neo-Bladder" Construct |
|---|---|
| Sponsor | Wake Forest University Health Sciences |
| Modality | Biologic |
| Phase | FDA-approved |
Approved indications
- BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma (Single Agent)
- BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma (Combination with Dabrafenib)
- Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma
- BRAF V600E Mutation-Positive Metastatic NSCLC
- BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer
- BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
- BRAF V600E Mutation-Positive Low-Grade Glioma in Pediatric Patients
Common side effects
- pyrexia
- rash
- headache
- vomiting
- musculoskeletal pain
- fatigue
- dry skin
- diarrhea
- nausea
- epistaxis and other bleeding events
- abdominal pain
- dermatitis acneiform
Drug interactions
- dabrafenib
Key clinical trials
- Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct (PHASE2)
- Study of Autologous Neo-Bladder Construct in Subjects With Neurogenic Bladder Following Spinal Cord Injury (PHASE2)
- Autologous Neo-Bladder Construct in Non-Neurogenic Overactive Bladder and Urge Predominant Incontinence (PHASE2)
- Augmentation Cystoplasty Using an Autologous Neo-Bladder (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- "Neo-Bladder" Construct CI brief — competitive landscape report
- "Neo-Bladder" Construct updates RSS · CI watch RSS
- Wake Forest University Health Sciences portfolio CI