Acthar

Phase 3Small molecule

MMallinckrodt

Acthar is one of 53 small molecule programs targeting Dermatomyositis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

DermatomyositisActive, not recruiting

NephropathyActive, not recruiting

BiomarkerRecruiting

DermatomyositisPreclinical

Active, not recruiting

NephropathyPreclinical

Active, not recruiting

BiomarkerPhase 3

Recruiting

Competition

Competitive Landscape

36 competitors in Nephropathy

#DrugCompanyPhaseTrials

Alka-Seltzer

AAbbott

Approved

14 2

Rocaltrol

Jazz Pharmaceuticals

Approved

2 3

Rituxan

Roche

Approved

2 4

Theo-Dur

Pfizer

Approved

2 5

Crestor

AstraZeneca

Approved

2 6

Micardis

Boehringer Ingelheim

Approved

2 7

Deltasone

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

2 8

Livalo

MMedicure

Approved

1 9

Atacand

IIstituto Clinico Humanitas

Approved

1 10

Nitrostat

VViatris Specialty LLC

Approved

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Biomarker

NCT02523092

Clinical

Trials by Indication[1]

Multiple Sclerosis4 trials

Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)

Completed·OOhioHealth·N/A·NCT02258217·30 enrolled

Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)

Terminated·MMallinckrodt ARD LLC·Phase 4·NCT03126760·35 enrolled

Comprehensive Analysis of Relapse in Multiple Sclerosis

Unknown status·TTanner Foundation for Multiple Sclerosis·N/A·NCT01906684·20 enrolled

Show 1 more trial

Modeling and Treating the Pathophysiology of Demyelination in Multiple Sclerosis

Terminated·EElliot Frohman·Phase 4·NCT00854750·1 enrolled

Rheumatoid Arthritis4 trials

ACTHAR for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

Terminated·—·Phase 2·NCT01984268·15 enrolled

ACTH Gel Therapy in Rheumatoid Arthritis

Completed·DDana Ascherman·N/A·NCT02030028·18 enrolled

The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis

Unknown status·AAttune Health Research, Inc.·Phase 3·NCT03511625·6 enrolled

Show 1 more trial

Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

Completed·MMallinckrodt·Phase 4·NCT02919761·259 enrolled

Nephrotic Syndrome2 trials

Experience With H.P. Acthar Gel Treatment of Patients With Nephrotic Syndrome/Proteinuria Due to Various Etiologies and Its Effect on Podocyte Function

Unknown status·GGreater Boston Medical Associates··NCT03644771·40 enrolled

Treatment of Resistant Nephrotic Syndrome With ACTH Gel (ACTHAR)

Completed·—·Phase 4·NCT01129284·15 enrolled

Optic Neuritis2 trials

Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis

Completed·NNeuro-Ophthalmologic Associates, PC·Phase 1·NCT01987167·25 enrolled

A Trial of Neuroprotection With ACTH in Acute Optic Neuritis

Terminated·UUniversity of Colorado, Denver·Phase 4·NCT01838174·37 enrolled

Systemic Lupus Erythematosus2 trials

Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease

Completed·MMallinckrodt·Phase 4·NCT01753401·38 enrolled

Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

Completed·MMallinckrodt·Phase 4·NCT02953821·172 enrolled

21 more indications

Kidney Transplant2 trials

Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

Terminated·UUniversity of Illinois at Chicago·Phase 4·NCT02057523·2 enrolled

Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar

Terminated·UUniversity of Maryland, Baltimore·Phase 4·NCT02546492·6 enrolled

Sarcoidosis2 trials

ACTHAR GEL for Sarcoidosis-Associated Calcium Dysregulation: An Open-label Pilot Study

Unknown status·—·Phase 2/3·NCT02155803·10 enrolled

ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial

Unknown status·—·Phase 2/3·NCT02348905·10 enrolled

Pulmonary Sarcoidosis2 trials

Acthar Gel in Participants With Pulmonary Sarcoidosis

Completed·MMallinckrodt·Phase 4·NCT03320070·55 enrolled

Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)

Unknown status·UUniversity of Cincinnati·Phase 4·NCT02188017·20 enrolled

Lupus Nephritis2 trials

ACTHar in the Treatment of Lupus Nephritis

Terminated·—·Phase 4·NCT02226341·8 enrolled

ACTHAR GEL in Patients With Membranous (Class V) Lupus Nephritis

Withdrawn·OOhio State University·Phase 4·NCT01926054

Psoriatic Arthritis1 trial

Clinical Impact of Acthar in the Psoriatic Arthritis Patient (CLIPS)

Completed·IIRIS Research and Development, LLC·Phase 4·NCT03419650·10 enrolled

Completed·MMallinckrodt·Phase 4·NCT04169061·36 enrolled

Anterior Uveitis1 trial

Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis

Terminated·WWashington University School of Medicine·Phase 4·NCT02769702·2 enrolled

Advanced1 trial

Effects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS Relapses

Terminated·UUniversity of Chicago·Phase 4·NCT03021317·5 enrolled

Membranous Nephropathy1 trial

Adrenocorticotropic Hormone in Membranous Nephropathy

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT03025828·5 enrolled

IgA Nephropathy1 trial

Acthar on Proteinuria in IgA Nephropathy Patients

Withdrawn·—·Phase 4·NCT02382523

Biomarker1 trial

Use of CXCL9 as a Biomarker of Acthar Efficacy

Recruiting·UUniversity of California, San Francisco·Phase 4·NCT02523092·14 enrolled

Methylprednisolone1 trial

Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS Relapses

Unknown status·AAaron Miller·N/A·NCT01900093·10 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Acthar Gel in an Outpatient Dialysis Population

Terminated·—·Phase 1·NCT02486744·9 enrolled

Proteinuria1 trial

Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria

Completed·MMallinckrodt ARD LLC·Phase 4·NCT02633046·63 enrolled

Effectiveness1 trial

Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)

Terminated·MMallinckrodt·Phase 4·NCT03656692·5 enrolled

Dermatomyositis1 trial

Dermatomyositis and Polymyositis Registry

Unknown status·PPhoenix Neurological Associates, LTD··NCT01637064·100 enrolled

Amyotrophic Lateral Sclerosis1 trial

Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)

Terminated·MMallinckrodt·Phase 2/3·NCT03068754·143 enrolled

Rheumatoid Arthritis (RA)1 trial

Use of Acthar in Rheumatoid Arthritis Related Flares

Completed·VVeena Ranganath, MD, MS·Approved·NCT02541955·40 enrolled

FSGS1 trial

The Use of Acthar (ACTH) in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Have Developed Chronic Kidney Disease Stage V (CKD) or End Stage Renal Disease (ESRD) and Are Undergoing a Renal Transplant

Completed·UUniversity of Colorado, Denver·Phase 3·NCT02683889·15 enrolled

Sources

References

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

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: MMallinckrodt

Acthar

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Multiple Sclerosis4 trials

Rheumatoid Arthritis4 trials

Nephrotic Syndrome2 trials

Optic Neuritis2 trials

Systemic Lupus Erythematosus2 trials

Kidney Transplant2 trials

Sarcoidosis2 trials

Pulmonary Sarcoidosis2 trials

Lupus Nephritis2 trials

Psoriatic Arthritis1 trial

Treatment1 trial

Nephropathy1 trial

Keratitis1 trial

Anterior Uveitis1 trial

Advanced1 trial

Membranous Nephropathy1 trial

IgA Nephropathy1 trial

Biomarker1 trial

Methylprednisolone1 trial

Safety and Efficacy1 trial

Proteinuria1 trial

Effectiveness1 trial

Dermatomyositis1 trial

Amyotrophic Lateral Sclerosis1 trial

Rheumatoid Arthritis (RA)1 trial

FSGS1 trial

References

Drug Info

Quick Facts

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