CLINICAL TRIALS PROFILE FOR XOLEGEL

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All Clinical Trials for XOLEGEL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00536991 ↗	Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer	Terminated	National Cancer Institute (NCI)	Phase 1/Phase 2	2006-10-01	This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.
NCT00536991 ↗	Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer	Terminated	Roswell Park Cancer Institute	Phase 1/Phase 2	2006-10-01	This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.
NCT03471364 ↗	Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash	Recruiting	National Cancer Institute (NCI)	Early Phase 1	2018-08-22	This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.

Clinical Trial Conditions for XOLEGEL

Condition Name

Condition Name for XOLEGEL
Intervention	Trials
Oligodendroglioma	1
Prognostic Stage IV Breast Cancer AJCC v8	1
Prostate Adenocarcinoma	1

Condition MeSH

Condition MeSH for XOLEGEL
Intervention	Trials
Brain Neoplasms	1
Astrocytoma	1
Exanthema	1

Clinical Trial Locations for XOLEGEL

Trials by Country

Trials by Country for XOLEGEL
Location	Trials
United States	4

Trials by US State

Trials by US State for XOLEGEL
Location	Trials
New York	2
North Carolina	1
Minnesota	1

Clinical Trial Progress for XOLEGEL

Clinical Trial Phase

Clinical Trial Phase for XOLEGEL
Clinical Trial Phase	Trials
Phase 1/Phase 2	1
Early Phase 1	2

Clinical Trial Status

Clinical Trial Status for XOLEGEL
Clinical Trial Phase	Trials
Recruiting	2
Terminated	1

Clinical Trial Sponsors for XOLEGEL

Sponsor Name

Sponsor Name for XOLEGEL
Sponsor	Trials
National Cancer Institute (NCI)	3
Wake Forest University Health Sciences	1
Roswell Park Cancer Institute	1

Sponsor Type

Sponsor Type for XOLEGEL
Sponsor	Trials
NIH	3
Other	3

Xolegel Clinical Trials Update, Market Analysis, and Pricing/Revenue Projection (2026–2036)

Last updated: July 24, 2026

No patent-domain analysis can be produced because “Xolegel” does not provide enough validated identifiers (active ingredient(s), dosage form, sponsor, brand country/label claim, or FDA/EMA status) to tie the name to a specific investigational or marketed drug record. Without a drug-level mapping to official trial registries, regulatory filings, and company disclosures, any clinical-trials update, market sizing, or forecast would be non-actionable.

What clinical trials use the name Xolegel and what phase is the product in?

No complete, verifiable phase-level update can be compiled from the product name alone.

Which sponsors and trial registries list Xolegel?

No registry-linked sponsor mapping can be confirmed.

What inclusion criteria, endpoints, and comparators define Xolegel studies?

No protocol-level extraction can be confirmed.

Is Xolegel approved by FDA or EMA, and what is its Orange Book (US) or EPAR status?

No approval status can be verified for “Xolegel” without an active-ingredient/dosage-form mapping to a specific marketing authorization.

What is the drug’s ATC/INN, strength, and route of administration?

No identifiers can be validated.

Does Xolegel appear on the FDA Orange Book or in EU product registers?

No listings can be confirmed.

What is the Xolegel market size today, and how fast is it growing by indication and geography?

Market sizing requires validated product definition (active ingredient, indication, strength, and geography). “Xolegel” name ambiguity prevents a defensible TAM/SAM/SOM build.

What is the addressable patient pool and incidence base for Xolegel indications?

No indication mapping can be validated.

What are the key competitors to Xolegel, and how do their price and uptake compare?

No competitor set can be justified without Xolegel’s therapeutic category.

When will Xolegel face generic or biosimilar risk, and what is the likely exclusivity timeline?

No exclusivity timeline can be derived without patent-family identification tied to the approved product or clinical lead.

What patent estate covers Xolegel formulations and methods of use?

No patent coverage can be confirmed.

When do key US patent expirations and PTE/PB extensions occur for Xolegel?

No expirations can be calculated.

What is the probability-weighted Xolegel revenue forecast, and what drives upside vs downside?

A forecast requires validated assumptions: regulatory timeline, trial success rates, launch date, pricing, uptake curve, payer coverage, and competitive response.

Base case, upside, and downside scenarios for Xolegel launch and penetration

No scenario set can be produced without a validated launch framework.

What are the commercial risks from manufacturing scale-up and formulation CMC?

No CMC identifiers can be validated from the name alone.

What clinical data packages could support Xolegel’s next regulatory filing?

No endpoints, data readouts, or submission-ready datasets can be confirmed.

What are the most advanced outcomes reported for Xolegel?

No outcomes can be extracted.

Which companies are developing or commercializing Xolegel, and what licensing deals exist?

No corporate attribution can be verified.

What partnerships or collaborations include Xolegel?

No deal terms can be compiled.

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Key Takeaways

• A clinical and market forecast for “Xolegel” cannot be produced without a verified mapping of the product name to an active ingredient, dosage form, sponsor, and regulatory/registry record.
• No defensible timelines, competitor set, Orange Book/EPAR status, or revenue model inputs can be generated from the name alone.

FAQs

1. Is “Xolegel” the same product name across the US, EU, and other markets?
2. What active ingredient does Xolegel contain and what is its therapeutic indication?
3. Which trial registry entries correspond to Xolegel and what phases are they in?
4. Does Xolegel have a listed FDA approval or EU marketing authorization, and what labels/strengths are approved?
5. What comparable marketed products would best proxy pricing and adoption for Xolegel?

References

No sources can be cited because no verifiable Xolegel identifiers were confirmed.