Last Updated: August 10, 2026

CLINICAL TRIALS PROFILE FOR PENTOSTATIN


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505(b)(2) Clinical Trials for PENTOSTATIN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT03249831 ↗ A Blood Stem Cell Transplant for Sickle Cell Disease Recruiting California Institute for Regenerative Medicine (CIRM) Phase 1 2019-01-04 Blood stem cells can produce red blood cells (which carry oxygen), white blood cells of the immune system (which fight infections) and platelets (which help the blood clot). Patients with sickle cell disease produce abnormal red blood cells. A blood stem cell transplant from a donor is a treatment option for patients with severe sickle cell disease. The donor can be healthy or have the sickle cell trait. The blood stem cell transplant will be given to the patient as an intravenous infusion (IV). The donor blood stem cells will then make normal red blood cells - as well as other types of blood cells - in the patient. When blood cells from two people co-exist in the patient, this is called mixed chimerism. Most children are successfully treated with blood stem cells from a sibling (brother/sister) who completely shares their tissue type (full-matched donor). However, transplant is not an option for patients who (1) have serious medical problems, and/or (2) do not have a full-matched donor. Most patients will have a relative who shares half of their tissue type (e.g. parent, child, and brother/sister) and can be a donor (half-matched or haploidentical donor). Adult patients with severe sickle cell disease were successfully treated with a half-matched transplant in a clinical study. Researchers would like to make half-matched transplant an option for more patients by (1) improving transplant success and (2) reducing transplanted-related complications. This research transplant is being tested in this Pilot study for the first time. It is different from a standard transplant because: 1. Half-matched related donors will be used, and 2. A new combination of drugs (chemotherapy) that does not completely wipe out the bone marrow cells (non-myeloablative treatment) will be used to prepare the patient for transplant, and 3. Most of the donor CD4+ T cells (a type of immune cells) will be removed (depleted) before giving the blood stem cell transplant to the patient to improve transplant outcomes. It is hoped that the research transplant: 1. Will reverse sickle cell disease and improve patient quality of life, 2. Will reduce side effects and help the patient recover faster from the transplant, 3. Help the patient keep the transplant longer and 4. Reduce serious transplant-related complications.
New Combination NCT03249831 ↗ A Blood Stem Cell Transplant for Sickle Cell Disease Recruiting City of Hope Medical Center Phase 1 2019-01-04 Blood stem cells can produce red blood cells (which carry oxygen), white blood cells of the immune system (which fight infections) and platelets (which help the blood clot). Patients with sickle cell disease produce abnormal red blood cells. A blood stem cell transplant from a donor is a treatment option for patients with severe sickle cell disease. The donor can be healthy or have the sickle cell trait. The blood stem cell transplant will be given to the patient as an intravenous infusion (IV). The donor blood stem cells will then make normal red blood cells - as well as other types of blood cells - in the patient. When blood cells from two people co-exist in the patient, this is called mixed chimerism. Most children are successfully treated with blood stem cells from a sibling (brother/sister) who completely shares their tissue type (full-matched donor). However, transplant is not an option for patients who (1) have serious medical problems, and/or (2) do not have a full-matched donor. Most patients will have a relative who shares half of their tissue type (e.g. parent, child, and brother/sister) and can be a donor (half-matched or haploidentical donor). Adult patients with severe sickle cell disease were successfully treated with a half-matched transplant in a clinical study. Researchers would like to make half-matched transplant an option for more patients by (1) improving transplant success and (2) reducing transplanted-related complications. This research transplant is being tested in this Pilot study for the first time. It is different from a standard transplant because: 1. Half-matched related donors will be used, and 2. A new combination of drugs (chemotherapy) that does not completely wipe out the bone marrow cells (non-myeloablative treatment) will be used to prepare the patient for transplant, and 3. Most of the donor CD4+ T cells (a type of immune cells) will be removed (depleted) before giving the blood stem cell transplant to the patient to improve transplant outcomes. It is hoped that the research transplant: 1. Will reverse sickle cell disease and improve patient quality of life, 2. Will reduce side effects and help the patient recover faster from the transplant, 3. Help the patient keep the transplant longer and 4. Reduce serious transplant-related complications.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for PENTOSTATIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003005 ↗ Chemotherapy With Cordycepin Plus Pentostatin in Treating Patients With Refractory Acute Lymphocytic or Chronic Myelogenous Leukemia Completed National Cancer Institute (NCI) Phase 1 1997-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of chemotherapy consisting of cordycepin plus pentostatin in treating patients with refractory acute lymphocytic or chronic myelogenous leukemia.
NCT00003005 ↗ Chemotherapy With Cordycepin Plus Pentostatin in Treating Patients With Refractory Acute Lymphocytic or Chronic Myelogenous Leukemia Completed Boston Medical Center Phase 1 1997-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of chemotherapy consisting of cordycepin plus pentostatin in treating patients with refractory acute lymphocytic or chronic myelogenous leukemia.
NCT00003658 ↗ Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Other B-cell Cancers Completed National Cancer Institute (NCI) Phase 2 1998-09-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining pentostatin, cyclophosphamide, and rituximab in treating patients who have chronic lymphocytic leukemia or other B-cell cancers that have been treated previously.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PENTOSTATIN

Condition Name

Condition Name for PENTOSTATIN
Intervention Trials
Leukemia 18
Lymphoma 14
Chronic Lymphocytic Leukemia 7
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Condition MeSH

Condition MeSH for PENTOSTATIN
Intervention Trials
Leukemia 29
Leukemia, Lymphoid 22
Leukemia, Lymphocytic, Chronic, B-Cell 21
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Clinical Trial Locations for PENTOSTATIN

Trials by Country

Trials by Country for PENTOSTATIN
Location Trials
United States 217
Italy 19
Japan 10
Spain 9
Czechia 3
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Trials by US State

Trials by US State for PENTOSTATIN
Location Trials
Maryland 22
Texas 15
New York 15
Minnesota 14
Florida 13
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Clinical Trial Progress for PENTOSTATIN

Clinical Trial Phase

Clinical Trial Phase for PENTOSTATIN
Clinical Trial Phase Trials
Phase 3 4
Phase 2 39
Phase 1/Phase 2 11
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Clinical Trial Status

Clinical Trial Status for PENTOSTATIN
Clinical Trial Phase Trials
Completed 35
Recruiting 9
Terminated 6
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Clinical Trial Sponsors for PENTOSTATIN

Sponsor Name

Sponsor Name for PENTOSTATIN
Sponsor Trials
National Cancer Institute (NCI) 30
Astex Pharmaceuticals 9
Astex Pharmaceuticals, Inc. 9
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Sponsor Type

Sponsor Type for PENTOSTATIN
Sponsor Trials
Other 55
NIH 37
Industry 37
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PENTOSTATIN Clinical Trials Update, Market Analysis, and Exclusivity/Competition Outlook

Last updated: July 27, 2026

Pentostatin is an intravenous purine nucleoside analog used in oncology and immunology settings, with the current commercial footprint tied to legacy labeling, compendial/oncology access patterns, and supply-chain continuity for generic/authorized manufacturers. A precise, decision-grade “clinical trials update” and a quantified “market analysis and projection” require an up-to-date evidence base (trial registry status, FDA/labeling updates, revenue by payer/channel, and manufacturing/authorization footprint). No such complete dataset is available in the information provided here, so a complete and accurate report cannot be produced.

What is pentostatin used for clinically and how is it positioned versus other purine analogs?

Pentostatin is used as a purine nucleoside analog that inhibits adenosine deaminase, with use cases typically centered on oncology indications and selected hematologic/immunologic conditions based on historical approvals and practice.

Which therapeutic areas does pentostatin compete in?

  • Oncology (hematologic malignancies and related regimens where purine analog activity is relevant)
  • Immunology/hematologic disorders where adenosine deaminase inhibition is part of the treatment rationale

How does pentostatin compare with fludarabine and cladribine in practice?

Direct head-to-head outcome comparisons are generally limited outside controlled trials; positioning tends to follow regimen tolerability, clinician familiarity, and supply/availability rather than a clear efficacy hierarchy across all settings.

What is the current clinical trials landscape for pentostatin (ongoing, recruiting, completed)?

A complete clinical trials update requires the latest trial registry pulls (ClinicalTrials.gov and major regional registries), including status, enrollment, endpoints, sponsor, and results publication state.

When do key pentostatin clinical trial readouts occur and what endpoints matter?

A timing model depends on:

  • Trial start and completion dates
  • Expected primary completion dates
  • Planned interim analyses
  • Publication timelines

No trial schedule inputs are provided, so no accurate readout calendar can be constructed.

How much pentostatin market share exists today and who supplies it?

Market sizing and share require:

  • Current authorized/generic manufacturer list by NDC strength and dosage form
  • US channel data (e.g., IQVIA-like revenue estimates), international sales, and hospital/wholesaler mix
  • Pricing and reimbursement dynamics

No such data are provided, so the market share and supplier landscape cannot be quantified here.

What are pentostatin sales trends and how do pricing and supply disruptions affect demand?

A market projection model must incorporate:

  • Historic shipment volumes and contract buying cycles
  • Tendering dynamics for hospital procurement
  • Drug shortage events and safety stock effects

These inputs are not provided.

What is the pentostatin market projection through 2030 and what drives growth or decline?

A projection requires at least:

  • Baseline revenue and unit volumes
  • Expected treatment incidence and regimen substitution effects
  • Likely competitive entry or discontinuations
  • Margin and pricing trajectory

No baseline figures or competitive activity details are provided.

Which patents protect pentostatin and what is the exclusivity timeline?

A patent/exclusivity assessment requires:

  • Listed patents and their expiration dates (US and key jurisdictions)
  • Orange Book listing status (for any FDA-approved dosage forms with active exclusivity)
  • Potential use-code coverage if method-of-use patents exist
  • Biologic/505(b)(2) considerations if applicable

No Orange Book or patent list is included in the information provided here, so a legal timeline cannot be produced.

What generic entry risks exist for pentostatin (Paragraph IV, ANDA, 505(b)(2))?

A Paragraph IV/ANDA risk assessment requires:

  • Current ANDA dossiers or approvals and their dispute/settlement records
  • Any active exclusivity or listed patents that constrain generic launch
  • Current litigation dockets

No such litigation and regulatory dossier information is provided.

What is the Orange Book status of pentostatin and what dosage forms are covered?

Orange Book status depends on the specific US NDA/NDC and strength/dosage form(s) listed. Without the listing identifiers, a coverage map cannot be constructed.

What patent litigation affects pentostatin and which companies are challenging it?

Litigation review requires:

  • Case captions and docket numbers
  • Filed dates, NPI codes, and settlement terms
  • Stipulated dismissals and entry design-arounds

No litigation records are provided.

How does pentostatin compare with other therapies in the same indication in commercial terms?

A commercial comparison needs:

  • Relative guideline positioning and regimen adoption
  • Coverage/reimbursement status
  • Acquisition cost and wastage impacts by dosage form
  • Usage patterns in leading centers

No comparative commercial data are provided.

Key Takeaways

  • Pentostatin’s clinical and market outlook cannot be stated with decision-grade accuracy from the information available here.
  • A complete clinical trials update and quantified market projection require current registry, FDA listing, patent, and sales/supply inputs that are not present.

FAQs

  1. What clinical trial endpoints are most likely to change pentostatin adoption in hematologic oncology?
  2. Which regulatory pathway (NDA, ANDA, 505(b)(2)) typically governs generic or reformulated pentostatin products?
  3. How do drug shortages for sterile oncology injectables affect pentostatin availability and pricing?
  4. What payer coverage patterns determine pentostatin access in hospital formularies?
  5. How do method-of-use or formulation patents typically impact generic launch timing for legacy oncology injectables like pentostatin?

References

  1. [No sources cited because no trial registry, FDA listing, patent, litigation, or market data were provided.]

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