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Intraepithelial neoplasia of the vulvar squamous epithelium. There is no evidence of invasion. This category includes vulvar high grade squamous intraepithelial lesion and vulvar intraepithelial neoplasia, differentiated type.
Biomarker and diagnostic research for vulvar intraepithelial neoplasia has been reported in the published literature.
No approved treatments are currently available for vulvar intraepithelial neoplasia. An additional 2 compounds hold orphan drug designation.
While no drugs are FDA-approved specifically for vulvar intraepithelial neoplasia, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.
The following drugs have received orphan drug designation from the FDA for vulvar intraepithelial neoplasia. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor |
|---|
Estimated prevalence: 1-5 in 10,000 (Uncommon).
1 clinical trial registered. Interventions under study include other interventions. Research is primarily sponsored by academic and government institutions.
99 publications have been identified in PubMed for vulvar intraepithelial neoplasia. Research spans Review / Meta-Analysis (25%), Diagnostic / Biomarker (22%), and Case Report / Case Series (20%).
Research Type | Count | % of Total |
|---|---|---|
Research summaries | 25 | 25% |
Data assembled from 5 of 12 sources · Last updated Sep 19, 2026, 10:16 AM UTC
European rare disease database
Genetic and Rare Diseases Info Center
Designated
Exclusivity End |
|---|
Designation Status |
|---|
artesunate | artesunate | Frantz Viral Therapeutics, LLC | 2025 | — | Designated |
imiquimod (IMQ)-ferulic acid (FA) co-crystal (IMQ API and FA coformer) | imiquimod (IMQ)-ferulic acid (FA) co-crystal (IMQ API and FA coformer) | Celista Pharmaceuticals LLC | 2022 | — | Designated |
Gene therapy approaches for vulvar intraepithelial neoplasia have been reported in the published literature.
1 trial found
Testing and diagnosis research |
22 |
22% |
Patient case studies | 20 | 20% |
Disease patterns and progression | 17 | 17% |
Laboratory research | 11 | 11% |
Clinical study results | 3 | 3% |
New treatment approaches | 1 | 1% |
Keese Z (2026). [PMID: 41971311](https://pubmed.ncbi.nlm.nih.gov/41971311/). *Gynecol Oncol Rep*. [Clinical Trial Publication]
Waugh SB (2026). [PMID: 42005806](https://pubmed.ncbi.nlm.nih.gov/42005806/). *Gynecol Oncol Rep*. [Case Report / Case Series]
Ege HV (2026). [PMID: 41746069](https://pubmed.ncbi.nlm.nih.gov/41746069/). *Vaccines (Basel)*. [Review / Meta-Analysis]
Vaessen VJGM (2026). [PMID: 41732168](https://pubmed.ncbi.nlm.nih.gov/41732168/). *Gynecol Oncol Rep*. [Review / Meta-Analysis]
de Vries DC (2026). [PMID: 41575668](https://pubmed.ncbi.nlm.nih.gov/41575668/). *Mol Diagn Ther*. [Diagnostic / Biomarker]
Madan V (2026). [PMID: 41105821](https://pubmed.ncbi.nlm.nih.gov/41105821/). *Clin Exp Dermatol*. [Review / Meta-Analysis]
Crimmins J (2026). [PMID: 41951322](https://pubmed.ncbi.nlm.nih.gov/41951322/). *Dermatol Clin*. [Review / Meta-Analysis]
Parker M (2026). [PMID: 40971563](https://pubmed.ncbi.nlm.nih.gov/40971563/). *Am J Dermatopathol*. [Case Report / Case Series]
Swaminathan S (2026). [PMID: 41928602](https://pubmed.ncbi.nlm.nih.gov/41928602/). *Clin Obstet Gynecol*. [Review / Meta-Analysis]
Ayala M (2026). [PMID: 31082026](https://pubmed.ncbi.nlm.nih.gov/31082026/). *Unknown Journal*. [Review / Meta-Analysis]