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Kepivance

(palifermin)

Phase 2Protein / enzyme

SSwedish Orphan Biovitrum

Palifermin is used to reduce severe mouth sores and damage to the inside of the mouth in cancer patients receiving high-dose chemotherapy or radiation therapy before a stem cell transplant.[1] Kepivance is currently being investigated across 10 indications[3], with its most advanced program in Phase 2.[1]

Kepivance is one of 138 biologic programs targeting Mucositis. It is currently in Phase 2.

10

Indications

49

Total Trials

10

Active Trials

137

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

MucositisUnknown

CD40L-Hyperigm SyndromeRecruiting

Acute Lymphoblastic LeukemiaActive, not recruiting

Chronic Granulomatous Disease (CGD)Recruiting

Allogeneic Hematopoietic Stem Cell Transplant RecipientActive, not recruiting

WHIMNot yet recruiting

Acute Myeloid LeukemiaRecruiting

X-Linked Severe Combined ImmunodeficiencyEnrolling by invitation

Crohn DiseaseNot yet recruiting

Allogeneic Hematopoietic Stem Cell TransplantationActive, not recruiting

MucositisPreclinical

Unknown

CD40L-Hyperigm SyndromePreclinical

Recruiting

Acute Lymphoblastic LeukemiaPhase 1

Active, not recruiting

Chronic Granulomatous Disease (CGD)Preclinical

Recruiting

Allogeneic Hematopoietic Stem Cell Transplant RecipientPhase 1

Active, not recruiting

WHIMPreclinical

Not yet recruiting

Acute Myeloid LeukemiaPhase 2

Recruiting

X-Linked Severe Combined ImmunodeficiencyPreclinical

Enrolling by invitation

Crohn DiseasePhase 2

Not yet recruiting

Allogeneic Hematopoietic Stem Cell TransplantationPhase 2

Active, not recruiting

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Novantrone

Xospata

Fludara

Cerubidine

EEastern Cooperative Oncology Group

Vepesid

Mylotarg

WWyeth-Lederle Vaccines

Vanflyta

Cerubidine

HHikma Pharmaceuticals LLC

Cellcept

Busulfex

Akero Therapeutics

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

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Allogeneic Hematopoietic Stem Cell Transplant Recipient

NCT04177004

Phase 2Active, not recruiting

Allogeneic Hematopoietic Stem Cell Transplantation

NCT01746849

Q2 2027

Phase 1Active, not recruiting

Acute Lymphoblastic Leukemia

NCT05139004

Q4 2027

PreclinicalRecruiting

CD40L-Hyperigm Syndrome

NCT06959771

Q2 2029

Phase 2Recruiting

Acute Myeloid Leukemia

NCT07582172

Clinical

Trials by Indication[1]

Oral Mucositis9 trials

Growth Factor to Prevent Oral Mucositis in Patients With Hematologic Cancer

Completed·JJonsson Comprehensive Cancer Center·Phase 2·NCT00004132

A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy

Completed·SSwedish Orphan Biovitrum·Phase 1/2·NCT00626639·5 enrolled

Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for Locally Advanced Head and Neck Cancer

Terminated· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00360971·21 enrolled

Show 6 more trials

Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant

Withdrawn·CChildren's Oncology Group·Phase 2·NCT00728585

Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer

Completed·SSwedish Orphan Biovitrum·Phase 3·NCT00101582·188 enrolled

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer

Completed· Amgen logo

Amgen·Phase 2/3·NCT00393822·100 enrolled

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy

Withdrawn·SSwedish Orphan Biovitrum·Phase 1/2·NCT00540332

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer

Completed· Amgen logo

Amgen·Phase 3·NCT00131638·241 enrolled

Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)

Completed·SSwedish Orphan Biovitrum·Phase 3·NCT00109031·47 enrolled

Multiple Myeloma2 trials

Melphalan, Total Marrow Irradiation, and Autologous Stem Cell Transplantation in Treating Patients With High-Risk Multiple Myeloma

Withdrawn·—·Phase 1/2·NCT03100877

Melphalan and Palifermin in Treating Patients Undergoing An Autologous Peripheral Stem Cell Transplant for Stage II or III Multiple Myeloma

Completed·BBarbara Ann Karmanos Cancer Institute·Phase 1·NCT00482846·38 enrolled

Lymphoma2 trials

Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Lymphoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT02961816

CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma

Terminated·—·Phase 2·NCT01746173·5 enrolled

Stem Cell Transplant2 trials

Human Lysozyme Goat Milk in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant

Withdrawn·—·Phase 1·NCT03531281

Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT02114502

Allogeneic Hematopoietic Stem Cell Transplantation2 trials

Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01746849·82 enrolled

Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT00701688·19 enrolled

30 more indications

Acute Lymphoblastic Leukemia2 trials

Standard Chemotherapy with or Without Nelarabine or Rituximab in Treating Patients with Newly Diagnosed Acute Lymphoblastic Leukemia

Completed·UUniversity College, London··NCT01085617

Phase I Study of Escalating Doses of 90Y-DOTA-Anti-CD25 Monoclonal Antibody Added to the Conditioning Regimen of Fludarabine, Melphalan, and Organ Sparing Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With High-Risk Acute Leukemia or Myelodysplastic Syndrome

Active, not recruiting·CCity of Hope Medical Center·Phase 1·NCT05139004·7 enrolled

X-linked Severe Combined Immunodeficiency2 trials

Lentiviral Gene Transfer for Treatment of Children Older Than 2 Years of Age With X-Linked Severe Combined Immunodeficiency

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT01306019·40 enrolled

Phase 1/2 Base-Edited Hematopoietic Stem/Progenitor Cell X-Linked Severe Combined Immunodeficiency Gene Therapy

Enrolling by invitation·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT06851767·18 enrolled

Non-Small Cell Lung Cancer1 trial

Study to Evaluate Palifermin in the Reduction of Dysphagia in Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Completed·SSwedish Orphan Biovitrum·Phase 2·NCT00094861·100 enrolled

Interaction1 trial

Palifermin DDI (Drug Drug Interaction)

Completed·SSwedish Orphan Biovitrum·Phase 1·NCT00361348·45 enrolled

Gemcitabine1 trial

High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01237951·75 enrolled

Multiple Sclerosis1 trial

Keratinocyte Growth Factor to Prevent Autoimmunity After Alemtuzumab Treatment of Multiple Sclerosis

Terminated·—·Phase 1/2·NCT01712945·40 enrolled

Chronic Graft Versus Host Disease1 trial

Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer

Completed·MMartin, Paul·N/A·NCT01233921·6 enrolled

Severe Combined Immunodeficiency1 trial

Lentiviral Gene Transfer for Treatment of Children Older Than 2 Years of Age With X-Linked Severe Combined Immunodeficiency

Unknown status·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT03315078·13 enrolled

Toxic Epidermal Necrolysis1 trial

Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis

Terminated·BBrett King·Phase 1/2·NCT02037347·1 enrolled

Hematopoietic Cell Transplant1 trial

Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00410982·145 enrolled

APL1 trial

Palifermin After Haploidentical PBSCT

Withdrawn·EEuropean Society for Blood and Marrow Transplantation·Phase 2·NCT00570999

Acute Leukemia1 trial

A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT

Completed·SSwedish Orphan Biovitrum·Phase 1·NCT00460421·27 enrolled

Acute Graft Versus Host Disease1 trial

Trial to Evaluate Palifermin in the Reduction of Acute Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Allogeneic Marrow/Peripheral Blood Progenitor Cell (PBPC) Transplantation

Completed·SSwedish Orphan Biovitrum·Phase 2·NCT00189488·155 enrolled

Hematopoietic Stem Cell Transplantation1 trial

Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation

Unknown status·TThe Catholic University of Korea·Phase 3·NCT02313792·88 enrolled

Recessive Dystrophic Epidermolysis Bullosa1 trial

Allogeneic Stem Cell Transplantation (ALLOSCT) in Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Terminated·—·Phase 1·NCT00881556·3 enrolled

Relapsed or Refractory1 trial

Vorinostat With Gemcitabine, Busulfan, and Melphalan With Stem Cell Transplant (SCT) in Relapsed or Refractory Lymphoid Malignancies

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01421173·78 enrolled

Allogeneic Hematopoietic Cell Transplant1 trial

Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT02356159·34 enrolled

Hematological Malignancies1 trial

Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

Terminated·—·Phase 2·NCT00593554·9 enrolled

Effectiveness1 trial

Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00376935·99 enrolled

Efficacy1 trial

Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00267046·49 enrolled

Hodgkin's Disease1 trial

High-Dose Gemcitabine, Busulfan and Melphalan for Patients With Refactory Hodgkin's Disease

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01200329·81 enrolled

Crohn Disease1 trial

Phase 1b/2a Trial of Allogeneic HSCT From an HLA-partially Matched Related or Unrelated Donor After TCRab+ T-cell/CD19+ B-cell Depletion for Patients With Monogenic and/or Early-onset Medically Refractory Crohn Disease

Not yet recruiting·SStanford University·Phase 1/2·NCT06986382·14 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Lenalidomide Combined With Vorinostat/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Diffuse Large B-Cell Lymphoma of the ABC Subtype

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT02589145·8 enrolled

Stem Cell Transplantation1 trial

Biological Therapy in Treating Patients Undergoing Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation for Hematologic Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00004061·111 enrolled

WHIM1 trial

Phase 1/2 Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM

Enrolling by invitation·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT07775313·10 enrolled

Acute Myeloid Leukemia1 trial

Phase 2 Trial of Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplantation (PBSC-HCT) From a Match Donor With Fludarabine and Melphalan in Older Patients With Refractory Acute Myeloid Leukemia and MDS

Recruiting·CCity of Hope Medical Center·Phase 2·NCT07582172·35 enrolled

Chronic Granulomatous Disease (CGD)1 trial

Phase 1/2 Trial of Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-linked Chronic Granulomatous Disease

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT06325709·15 enrolled

CD40L-HyperIgM Syndrome1 trial

Base Editing Hematopoietic Stem Cell and BE T Cell Gene Therapy for CD40L-HyperIgM Syndrome-Single Patient Study

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT06959771·1 enrolled

Allogeneic Hematopoietic Stem Cell Transplant Recipient1 trial

A Randomized Pilot Study of Human Lysozyme Goat Milk in Recipients of Standard Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation

Active, not recruiting·CCity of Hope Medical Center·Phase 1·NCT04177004·52 enrolled

Unspecified1 trial

Study to Characterize the Effect of Heparin on Palifermin Activity

Completed·SSwedish Orphan Biovitrum·Phase 1·NCT01163097·44 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 15, 2004

KEPIVANCE

BLA BLA125103

Sources

References

[1]
ClinicalTrials.gov — 49 trial records for palifermin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — palifermin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for palifermin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA125103). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Swedish Orphan Biovitrum company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Fibroblast Growth Factor Receptor 2 Agonist[2]
Modality: Protein / enzyme[2]
Highest Phase: Phase 2[1]
Company: SSwedish Orphan Biovitrum

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