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Actimmune

(interferon gamma-1b)

Phase 3Small molecule

HHorizon Therapeutics Ireland DAC

Interferon gamma-1b is used to treat certain serious infections and a rare genetic disorder called chronic granulomatous disease, where the body's immune system doesn't work properly to fight off infections.[1] Actimmune is currently being investigated across 43 indications[3], with its most advanced program in Phase 3.[1]

Actimmune is one of 865 small molecule programs targeting HIV infection. It is currently in Phase 3.

43

Indications

30

Total Trials

2

Active Trials

864

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

HIV InfectionActive, not recruiting

Cirrhosis of LiverActive, not recruiting

Bronchiolitis ObliteransActive, not recruiting

Non-Hodgkins LymphomaActive, not recruiting

Cryptococcal MeningitisActive, not recruiting

Leukocyte-Adhesion Deficiency SyndromeActive, not recruiting

Hepatic FibrosisUnknown

AspergillosisActive, not recruiting

Anterior UveitisActive, not recruiting

RetinopathyActive, not recruiting

HIV InfectionPhase 2

Active, not recruiting

Cirrhosis of LiverPhase 2

Active, not recruiting

Bronchiolitis ObliteransPhase 2

Active, not recruiting

Non-Hodgkins LymphomaPhase 1

Active, not recruiting

Cryptococcal MeningitisPhase 2

Active, not recruiting

Leukocyte-Adhesion Deficiency SyndromePhase 2

Active, not recruiting

Hepatic FibrosisPreclinical

Unknown

AspergillosisPhase 2

Active, not recruiting

Anterior UveitisPhase 1

Active, not recruiting

RetinopathyPhase 1/Phase 2

Active, not recruiting

Showing 10 of 43 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Actimmune

HHorizon Therapeutics Ireland DAC

Blenoxane

SSequus Pharmaceuticals

Norvir

Wellcovorin

GGlaxo Dba Glaxosmithkline

Tafasitamab

Nuvigil

NNuvo Research GmbH

PEG-Intron

Systemic Therapy

Bristol-Myers Squibb

Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Immune Checkpoint Inhibitor

IImmuneSensor Therapeutics Inc.

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

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Myelodysplastic Syndromes

NCT06529731

Q2 2031

Phase 2Not yet recruiting

Sepsis

NCT06381661

Clinical

Trials by Indication[1]

Idiopathic Pulmonary Fibrosis4 trials

A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Completed·IInterMune·Phase 3·NCT00047645·330 enrolled

A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Completed·IInterMune·Phase 2·NCT00047658·32 enrolled

The INSPIRE Trial: A Study of Interferon Gamma-1b for Idiopathic Pulmonary Fibrosis (IPF)

Terminated·IInterMune·Phase 3·NCT00075998·826 enrolled

Show 1 more trial

An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Completed·IInterMune·Phase 2·NCT00052052·210 enrolled

Safety and Efficacy3 trials

Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection

Terminated·IInterMune·Phase 2·NCT00043355·100 enrolled

Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer

Terminated·IInterMune·Phase 3·NCT00047632·847 enrolled

A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone

Terminated·IInterMune·Phase 3·NCT00052039

Cystic Fibrosis2 trials

Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis

Completed·IInterMune·Phase 1/2·NCT00043342·51 enrolled

Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis

Completed·IInterMune·Phase 1/2·NCT00043316·66 enrolled

Children1 trial

Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000761·20 enrolled

Mycosis Fungoides1 trial

Testing the Combination of Two Experimental Drugs MK-3475 (Pembrolizumab) and Interferon-gamma for the Treatment of Mycosis Fungoides and Sézary Syndrome and Advanced Synovial Sarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03063632·28 enrolled

19 more indications

Osteopetrosis1 trial

ACTIMMUNE in Intermediate Osteopetrosis

Completed·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 2·NCT02666768·5 enrolled

Lymphoma1 trial

Safety of Interferon Gamma-1b With Rituximab in Non-Hodgkin's Lymphoma Patients

Terminated·IInterMune·Phase 1/2·NCT00057447·24 enrolled

Effectiveness1 trial

The Safety and Effectiveness of Injections of Human Recombinant Interferon-gamma in Patients With AIDS Who Have Taken Zidovudine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001112·5 enrolled

AIDS1 trial

The Effects of r-metHuIFN-Gamma on the Lungs of Patients With AIDS

Completed· Amgen logo

Amgen·N/A·NCT00002433·12 enrolled

Macular Edema1 trial

Interferon Gamma-1b Administered Topically for Macular Edema/Intraretinal Schisis Cysts in Rod-Cone Dystrophy (RCD) and Enhanced S-Cone Syndrome (ESCS)

Terminated·NNational Eye Institute (NEI)·Phase 1/2·NCT02338973·4 enrolled

Friedreich ataxia1 trial

Interferon Gamma-1b in Friedreich Ataxia (FRDA)

Completed·—·Phase 2·NCT01965327·12 enrolled

Myelodysplastic Syndromes1 trial

Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation

Recruiting·SSawa Ito, MD·Phase 2·NCT06529731·45 enrolled

Necrosis1 trial

A Study of Tumor Necrosis Factor and Human Interferon-gamma in Patients With AIDS Related Complex

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001004·30 enrolled

IPF1 trial

An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF

Terminated·IInterMune·Phase 3·NCT00076635·91 enrolled

Cryptococcal Meningitis1 trial

Safety and Antifungal Activity of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Cryptococcal Meningitis

Completed·IInterMune·Phase 2·NCT00012467·60 enrolled

Unresectable1 trial

Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer

Terminated·FFred Hutchinson Cancer Center·Phase 1/2·NCT03747484·7 enrolled

Uveitis1 trial

Topical Interferon Gamma for Macular Edema Secondary to Uveitis

Completed·NNational Eye Institute (NEI)·Phase 1/2·NCT01376362·5 enrolled

Hepatitis C1 trial

Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis

Completed·IInterMune·Phase 2·NCT00043303·502 enrolled

Sepsis1 trial

Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT06381661·2,000 enrolled

Bronchiolitis Obliterans1 trial

A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT

Unknown status·UUniversity Hospital Regensburg·Phase 2·NCT01639261·10 enrolled

Retinopathy1 trial

Topical Interferon Gamma-1b for Central Serous Chorioretinopathy

Completed·NNational Eye Institute (NEI)·Phase 1/2·NCT01468337·5 enrolled

Chronic Granulomatous Disease1 trial

Role of Interferon-gamma 1-b (IFN-γ) on Cells of the Innate Immune System: Functional, Biochemical and Gene Expression Studies in Patients With Chronic Granulomatous Disease

Completed·UUniversity of Colorado, Denver··NCT03548818·9 enrolled

Immune1 trial

Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers

Unknown status·VVidara Therapeutics Research Ltd·Phase 1·NCT01929382·40 enrolled

Candidemia1 trial

Safety and Efficacy of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Candidemia

Completed·RRadboud University Medical Center·Phase 2·NCT04979052·65 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 25, 1999

ACTIMMUNE

BLA BLA103836

Sources

References

[1]
ClinicalTrials.gov — 30 trial records for interferon gamma-1b. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — interferon gamma-1b compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for interferon gamma-1b. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA103836). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Horizon Therapeutics Ireland DAC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Interferon Gamma Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: HHorizon Therapeutics Ireland DAC

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