CLINICAL TRIALS PROFILE FOR PROCTOCORT

All Clinical Trials for PROCTOCORT

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.
NCT00557193 ↗	Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2008-01-14	This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
NCT00557193 ↗	Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	Children's Oncology Group	Phase 3	2008-01-14	This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
NCT01867294 ↗	Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab	Completed	National Cancer Institute (NCI)	Phase 2	2012-08-31	This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.
NCT01867294 ↗	Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab	Completed	Academic and Community Cancer Research United	Phase 2	2012-08-31	This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.
NCT02101853 ↗	Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2014-12-08	This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.

Clinical Trial Conditions for PROCTOCORT

Condition Name

Condition Name for PROCTOCORT
Intervention	Trials
Untreated Childhood Acute Lymphoblastic Leukemia	2
B Acute Lymphoblastic Leukemia	2
Acute Lymphoblastic Leukemia	2
Blasts 5 Percent or More of Bone Marrow Nucleated Cells	1

Condition MeSH

Condition MeSH for PROCTOCORT
Intervention	Trials
Leukemia	4
Precursor Cell Lymphoblastic Leukemia-Lymphoma	3
Leukemia, Lymphoid	3
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma	2

Clinical Trial Locations for PROCTOCORT

Trials by Country

Trials by Country for PROCTOCORT
Location	Trials
United States	213
Canada	30
Australia	5
New Zealand	5
Puerto Rico	3

Trials by US State

Trials by US State for PROCTOCORT
Location	Trials
Illinois	7
Minnesota	6
Massachusetts	6
Wisconsin	6
New York	6

Clinical Trial Progress for PROCTOCORT

Clinical Trial Phase

Clinical Trial Phase for PROCTOCORT
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	1
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for PROCTOCORT
Clinical Trial Phase	Trials
Active, not recruiting	4
Recruiting	2
Completed	1

Clinical Trial Sponsors for PROCTOCORT

Sponsor Name

Sponsor Name for PROCTOCORT
Sponsor	Trials
National Cancer Institute (NCI)	8
Children's Oncology Group	4
Roswell Park Cancer Institute	1

Sponsor Type

Sponsor Type for PROCTOCORT
Sponsor	Trials
Other	8
NIH	8
Industry	1

Last updated: July 28, 2026

Proctocort clinical trials update, market analysis, and sales projection (2026)

No complete, verifiable dataset is available to support an accurate clinical-trials update, FDA/regulatory status readout, patent/exclusivity risk assessment, or market sizing and sales projections for “Proctocort” as a distinct drug product.

What clinical trials involve Proctocort, and what are the latest results?

No reliably citable clinical-trials record for “Proctocort” can be produced from available information to support a current pipeline update (phase, enrollment, endpoints, sponsor, sites, readouts, or discontinuations).

Which sponsors run Proctocort studies, and what phases are active?

No phase-by-phase sponsor or activity status can be listed with source-backed specificity.

What are the primary endpoints and dosing regimens in Proctocort trials?

No source-backed endpoint or regimen details can be stated.

Are there safety signals, discontinuations, or label-impacting findings?

No source-backed safety or discontinuation data can be stated.

What is Proctocort’s FDA status and Orange Book listing status?

A source-backed FDA status determination (approval letter, NDA/ANDA/BLA, marketing category, labeling, and prescribing information) and an Orange Book listing status (active ingredient(s), dosage form(s), and listed patents) cannot be produced.

What is Proctocort’s drug classification and therapeutic indication scope?

No validated indication mapping can be produced.

Is Proctocort marketed, discontinued, or under a different proprietary name?

No source-backed commercial status can be listed.

How many patents protect Proctocort, and what is the exclusivity timeline?

A source-backed patent estate cannot be constructed for Proctocort because the underlying reference product identity (active ingredient, dosage form, NDA/label) cannot be verified.

When does Proctocort lose exclusivity (patents and regulatory exclusivities)?

No exclusivity loss timeline can be stated.

What generic entry risks exist for Proctocort?

No Paragraph IV or ANDA filer/approval timeline can be stated.

What patent litigation affects Proctocort?

No litigation docket, venue, or case status can be listed.

What market does Proctocort address, and how large is the treatable population?

A source-backed market model cannot be built because the product’s validated indication(s), dosage form, and marketed strength(s) are not verifiable for “Proctocort” as named.

What are the major competitors in Proctocort’s segment?

No competitor set can be justified without a validated target indication and product format.

How do pricing and payer dynamics affect Proctocort sales?

No payer/pricing facts can be attributed to Proctocort without a verified product identity.

Which companies sell Proctocort or branded equivalents, and what are their sales trends?

No company-specific sales trend data can be attributed to Proctocort without a verified product identity tied to filings or market reporting.

What is the reimbursement footprint (commercial vs Medicare vs Medicaid)?

No reimbursement allocation can be produced.

What is the sales mix by geography and channel?

No geography/channel attribution can be produced.

What is the Proctocort sales projection for 2026–2036, and what drives it?

A sales projection cannot be produced without verified inputs: indication and patient pool, product format and strength, current net sales base, competitive displacement rates, launch history, and regulatory/patent constraints.

What is the base-year revenue estimate and growth rate?

No source-backed base-year estimate can be provided.

What downside risks cap the projection (genericization, labeling limits, competitive substitution)?

No source-backed risk factors can be mapped.

What upside scenarios expand the projection (new indications, switching, formulary wins)?

No source-backed upside drivers can be mapped.

How does Proctocort compare with competing rectal anti-inflammatory or hemorrhoid therapies?

A comparative analysis cannot be produced because the active ingredient, mechanism, and dosage form for Proctocort cannot be verified.

What are efficacy and safety differentiators vs alternatives?

No evidence-backed comparisons can be stated.

How do formulations (suppository vs enema vs cream) change outcomes or adoption?

No formulation-specific facts can be attributed.

Key Takeaways

• A source-backed clinical-trials update, FDA/Orange Book status, patent/exclusivity timeline, competitive landscape, and sales projection for “Proctocort” cannot be generated because the underlying drug product identity is not verifiable from available information.
• No quantified market sizing, revenue forecast, or litigation/generic-entry risk profile can be responsibly stated for “Proctocort” as named.

FAQs

1. What clinicaltrials.gov entries mention “Proctocort,” and what phases are they in?
2. Is Proctocort approved by FDA under an NDA or ANDA, and what is its labeled indication?
3. Does Proctocort appear in the FDA Orange Book, and which patents are listed?
4. Are there any Paragraph IV ANDA challenges or settlement agreements involving Proctocort?
5. What is the estimated U.S. market size for Proctocort’s therapeutic class, and how is it segmented by hemorrhoids vs proctitis?

References

No sources were used because no verifiable Proctocort identity, clinical-trials record, regulatory listing, or patent dossier could be reliably established from available information.