Emapalumab

Phase 3Monoclonal antibody

SSwedish Orphan Biovitrum

Emapalumab is one of 169 small molecule programs targeting Aplastic Anemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

168

Competitors

Pipeline

Status by Indication[3][1]

Indication

Aplastic AnemiaActive, not recruiting

Systemic Juvenile Idiopathic ArthritisActive, not recruiting

HistiocytosisActive, not recruiting

Interstitial Lung DiseaseActive, not recruiting

Acute Myeloid LeukemiaRecruiting

COVID-19Active, not recruiting

EnteritisActive, not recruiting

Aplastic AnemiaPhase 2

Active, not recruiting

Systemic Juvenile Idiopathic ArthritisPhase 2

Active, not recruiting

HistiocytosisPhase 3

Active, not recruiting

Interstitial Lung DiseasePhase 2

Active, not recruiting

Acute Myeloid LeukemiaPhase 1

Recruiting

COVID-19Phase 2/Phase 3

Active, not recruiting

EnteritisPhase 2

Active, not recruiting

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Emapalumab

SSwedish Orphan Biovitrum

Phase 3

1 2

COVID-19 Vaccine

Moderna

Preclinical

27 3

Aldactone

Pfizer

Preclinical

1 4

Nexavar

Bayer

Preclinical

1 5

Tricor

JJagotec

Preclinical

1 6

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 7

Benadryl

PParkedale

Preclinical

1 8

Olokizumab

UCB

Preclinical

1 9

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

1 10

Blood Taken

HHospices Civils de Lyon

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Stem Cell Transplant

NCT05787574

Q2 2027

Phase 2Not yet recruiting

Interstitial Lung Disease

NCT07486869

Phase 1Recruiting

Acute Myeloid Leukemia

NCT06996119

Q3 2027

Phase 2Recruiting

Prevention

NCT06550141

Q3 2028

Phase 2Recruiting

Cell Therapy

NCT06285825

Clinical

Trials by Indication[1]

Histiocytosis2 trials

A Study for Long-term Follow-up of Hemophagocytic Lymphohistiocytosis (HLH) Participants Who Received Treatment With Emapalumab (NI-0501), an Anti-interferon Gamma Monoclonal Antibody

Completed·SSwedish Orphan Biovitrum·Phase 2/3·NCT02069899·58 enrolled

Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis

Completed·SSwedish Orphan Biovitrum·Phase 3·NCT03312751·35 enrolled

Enteritis1 trial

Randomized Stepped Wedge Study of Emapalumab in APECED Enteritis

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT07202598·10 enrolled

Cell Therapy1 trial

A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06285825·32 enrolled

Prevention1 trial

Emapalumab Prevention of CAR-T Cell Associated Toxicities

Recruiting·MMarcela V. Maus, M.D.,Ph.D.·Phase 2·NCT06550141·28 enrolled

Stem Cell Transplant1 trial

A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05787574·39 enrolled

7 more indications

Efficacy and Safety1 trial

Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After HSCT.

Terminated·SSwedish Orphan Biovitrum·Phase 2·NCT04731298·2 enrolled

COVID-191 trial

Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.

Terminated·SSwedish Orphan Biovitrum·Phase 2/3·NCT04324021·16 enrolled

Children1 trial

Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE

Completed·SSwedish Orphan Biovitrum·Phase 3·NCT05001737·33 enrolled

Aplastic Anemia1 trial

A Study of Emapalumab for Pediatric Aplastic Anemia

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06430788·35 enrolled

Systemic Juvenile Idiopathic Arthritis1 trial

A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)

Completed·SSwedish Orphan Biovitrum·Phase 2·NCT03311854·14 enrolled

Interstitial Lung Disease1 trial

Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study

Not yet recruiting·UUniversity of Miami·Phase 2·NCT07486869·5 enrolled

Acute Myeloid Leukemia1 trial

Pilot Study of Emapalumab With Post-Transplant Cyclophosphamide as Graft-Versus-Host Disease Prophylaxis for Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation

Recruiting·CCity of Hope Medical Center·Phase 1·NCT06996119·15 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Emapalumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Emapalumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Emapalumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Swedish Orphan Biovitrum company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: SSwedish Orphan Biovitrum

Emapalumab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Q3 2028

Trials by Indication[1]

Histiocytosis2 trials

Enteritis1 trial

Cell Therapy1 trial

Prevention1 trial

Stem Cell Transplant1 trial

Efficacy and Safety1 trial

COVID-191 trial

Children1 trial

Aplastic Anemia1 trial

Systemic Juvenile Idiopathic Arthritis1 trial

Interstitial Lung Disease1 trial

Acute Myeloid Leukemia1 trial

References

Drug Info

Quick Facts

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