Nipent

(Pentostatin)

ApprovedSmall molecule

Nipent is a small molecule that works as Adenosine Deaminase Inhibitor.[2] It is being used across 14 indications, with its most advanced program in Approved.[1]

Nipent is one of 438 small molecule programs targeting Kidney Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

437

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Kidney CancerActive, not recruiting

LymphomaActive, not recruiting

Hairy Cell LeukemiaActive, not recruiting

LeukemiaApproved

MesotheliomaActive, not recruiting

Acute Graft Versus Host DiseaseActive, not recruiting

Chronic Graft Versus Host DiseaseActive, not recruiting

AnemiaActive, not recruiting

Bone Marrow TransplantationActive, not recruiting

Severe Aplastic AnemiaActive, not recruiting

Kidney CancerPhase 2

Active, not recruiting

LymphomaPhase 2

Active, not recruiting

Hairy Cell LeukemiaPhase 2

Active, not recruiting

LeukemiaApproved

Approved

MesotheliomaPhase 1/Phase 2

Active, not recruiting

Acute Graft Versus Host DiseasePhase 2

Active, not recruiting

Chronic Graft Versus Host DiseasePhase 2

Active, not recruiting

AnemiaApproved

Active, not recruiting

Bone Marrow TransplantationPhase 3

Active, not recruiting

Severe Aplastic AnemiaPhase 1

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Nipent

Pfizer

Approved

1 2

Oncaspar

SServier

Preclinical

15 3

Velban

EEastern Cooperative Oncology Group

Preclinical

15 4

Norvir

AbbVie

Preclinical

1 5

Wellcovorin

GGlaxo Dba Glaxosmithkline

Preclinical

4 6

Tafasitamab

Incyte

Preclinical

7 7

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

PEG-Intron

1 9

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 10

VP-16

FFundamenta Therapeutics, Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1/2Active, not recruiting

Sickle Cell Disease

NCT03077542

Q1 2027

Phase 1Active, not recruiting

Sickle Cell Disease

NCT03249831

Q2 2027

Phase 1Recruiting

Severe Aplastic Anemia

NCT05757310

Q4 2027

Phase 2Active, not recruiting

Sickle Cell Disease

NCT02105766

Phase 2Active, not recruiting

Hairy Cell Leukemia

NCT01059786

Clinical

Trials by Indication[1]

Chronic Lymphocytic Leukemia13 trials

Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma

Completed·HHoag Memorial Hospital Presbyterian·Phase 2·NCT00049413

Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Completed·PPharmatech Oncology·Phase 2·NCT00026351

Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Treating Patients With Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT00546377·50 enrolled

Show 10 more trials

Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia

Completed·OOhio State University Comprehensive Cancer Center·Phase 2·NCT00201721·28 enrolled

Ofatumumab, Pentostatin, and Cyclophosphamide in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed·MMayo Clinic·Phase 2·NCT01024010·82 enrolled

Pentostatin, Alemtuzumab, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed·MMayo Clinic·Phase 2·NCT00669318·41 enrolled

Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma

Terminated·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1·NCT01352312·10 enrolled

Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Other B-cell Cancers

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00003658·60 enrolled

Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00541034·49 enrolled

Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients

Completed·UUS Oncology Research·Phase 3·NCT00254163·184 enrolled

Pentostatin, Cyclophosphamide, and Rituximab With or Without Bevacizumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed·MMayo Clinic·Phase 2·NCT00816595·68 enrolled

Trial of Pentostatin Plus Cyclophosphamide With Ofatumumab (PCO) in Older Patients With Chronic Lymphocytic Leukemia

Completed·NNiguarda Hospital·Phase 2·NCT01681563·47 enrolled

Rituximab, Pentostatin, Cyclophosphamide, and Lenalidomide in Treating Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed·MMayo Clinic·Phase 2·NCT00602836·45 enrolled

Sickle Cell Disease3 trials

Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure

Active, not recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT02105766·56 enrolled

Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease

Active, not recruiting·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1/2·NCT03077542·57 enrolled

A Blood Stem Cell Transplant for Sickle Cell Disease

Active, not recruiting·—·Phase 1·NCT03249831·3 enrolled

Stem Cell Transplant3 trials

Safety and Efficacy of Pentostatin and Low Dose TBI With Allogenic Peripheral Blood Stem Cell Transplant

Completed·UUniversity of Nebraska·Phase 2·NCT00571662·76 enrolled

Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00096161·36 enrolled

Donor Stem Cell Transplant, Pentostatin, and Total-Body Irradiation in Treating Patients With Hematological Cancer

Withdrawn·UUniversity of Nebraska·Phase 1/2·NCT00816413

Acute Graft Versus Host Disease2 trials

Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease

Completed·OOhio State University Comprehensive Cancer Center·Phase 2·NCT00201786·8 enrolled

Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00224874·180 enrolled

Kidney Cancer2 trials

Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer

Completed·JJonsson Comprehensive Cancer Center·Phase 1/2·NCT00006968·4 enrolled

Low-Intensity Stem Cell Transplantation With Multiple Lymphocyte Infusions to Treat Advanced Kidney Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00923845·25 enrolled

14 more indications

Bone Marrow Transplantation2 trials

Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies

Completed·SSt. Jude Children's Research Hospital·Phase 3·NCT01188798·6 enrolled

A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)

Completed· Incyte logo

Incyte·Phase 3·NCT03112603·330 enrolled

Chronic Graft Versus Host Disease2 trials

Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00074035·39 enrolled

Pentostatin for High Risk and Refractory Chronic Graft Versus Host Disease in Children

Completed·—·Phase 2·NCT00144430·60 enrolled

Methotrexate1 trial

Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After MUD BMT

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT00506922·150 enrolled

Hairy Cell Leukemia1 trial

Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT01059786·69 enrolled

Mesothelioma1 trial

SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01362790·55 enrolled

Allogeneic Hematopoietic Cell Transplant1 trial

Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03663933·71 enrolled

Allogeneic Stem Cell Transplantation1 trial

A Trial of Extracorporeal Photopheresis, Pentostatin, and Total Body Irradiation in Patients Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation for the Treatment of Malignancies

Completed·YYale University·Phase 2·NCT00402714·14 enrolled

Relapsed or Refractory1 trial

Pentostatin, Cyclophosphamide, and Rituximab Followed By Campath-1H in Patients With Relapsed or Refractory B-Cell CLL

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00074282·102 enrolled

T-Cell Neoplasm1 trial

Alemtuzumab and Pentostatin In T-cell Neoplasms

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00453193·26 enrolled

Phase II1 trial

Phase II Trial of Pentostatin and Targeted Busulfan

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT00496340·42 enrolled

Severe Aplastic Anemia1 trial

A Reduced-Intensity Conditioning Regimen (Cyclophosphamide, Pentostatin, Anti-thymocyte Globulin) Followed by Haploidentical Hematopoietic Stem Cell Transplant for the Treatment of Patients With Refractory or Recurrent Severe Aplastic Anemia

Recruiting·—·Phase 1·NCT05757310·6 enrolled

Peripheral Blood Stem Cell Transplantation1 trial

Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation

Terminated·UUniversity of Arizona·Phase 2·NCT00698685·14 enrolled

Lymphoma1 trial

Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma

Terminated·EEastern Cooperative Oncology Group·Phase 2·NCT00057954·6 enrolled

Myelodysplastic Syndromes1 trial

Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00045305·17 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 11, 1991

NIPENT

NDA NDA020122

Sources

References

[1]
ClinicalTrials.gov — 39 trial records for Pentostatin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pentostatin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pentostatin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020122). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adenosine Deaminase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Pfizer

Nipent

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q1 2027

Q2 2027

Q4 2027

Trials by Indication[1]

Chronic Lymphocytic Leukemia13 trials

Sickle Cell Disease3 trials

Stem Cell Transplant3 trials

Acute Graft Versus Host Disease2 trials

Kidney Cancer2 trials

Bone Marrow Transplantation2 trials

Chronic Graft Versus Host Disease2 trials

Methotrexate1 trial

Hairy Cell Leukemia1 trial

Mesothelioma1 trial

Allogeneic Hematopoietic Cell Transplant1 trial

Allogeneic Stem Cell Transplantation1 trial

Relapsed or Refractory1 trial

T-Cell Neoplasm1 trial

Phase II1 trial

Severe Aplastic Anemia1 trial

Peripheral Blood Stem Cell Transplantation1 trial

Lymphoma1 trial

Myelodysplastic Syndromes1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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