8-Mop

(Methoxsalen)

Phase 3Small molecule

TTherakos, Inc., a Mallinckrodt Company

8-Mop is one of 141 small molecule programs targeting Colitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

140

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

ColitisActive, not recruiting

Cutaneous T-Cell LymphomaActive, not recruiting

Acute Graft Versus Host DiseaseActive, not recruiting

Rheumatoid ArthritisActive, not recruiting

Epidermolysis BullosaActive, not recruiting

ColitisPhase 2

Active, not recruiting

Cutaneous T-Cell LymphomaPhase 2

Active, not recruiting

Acute Graft Versus Host DiseasePhase 3

Active, not recruiting

Rheumatoid ArthritisPhase 2

Active, not recruiting

Epidermolysis BullosaPhase 2

Active, not recruiting

Competition

Competitive Landscape

791 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

8-Mop

TTherakos, Inc., a Mallinckrodt Company

Phase 3

1 2

Orencia

Bristol-Myers Squibb

Preclinical

47 3

Actemra

Enbrel

64 5

Arcoxia

Novartis

Preclinical

4 6

Actos

Takeda

Preclinical

2 7

Kineret

SSwedish Orphan Biovitrum

Preclinical

6 8

Vibramycin

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

Preclinical

2 9

Velcade

SShilpa Grover, MD, MPH

Preclinical

2 10

Cimzia

UCB

Preclinical

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

Timeline

Expected Milestones

Q4 2028

Recruiting

Sezary Syndrome

NCT05157581

Clinical

Trials by Indication[1]

Acute Graft Versus Host Disease2 trials

Methoxsalen and Extracorporeal Photopheresis (ECP) for the Treatment of Pediatric Participants With Steroid Refractory Acute Graft Versus Host Disease

Terminated·TTherakos, Inc., a Mallinckrodt Company·Phase 3·NCT02524847·29 enrolled

Biomarkers in Acute Graft-Versus-Host Disease and Extracorporeal Photopheresis Added to Investigator Chosen Therapies of Steroid Refractory Acute GVHD

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT02322190·5 enrolled

Graft Versus Host Disease2 trials

Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-versus-Host Disease

Completed·MMallinckrodt·Phase 2·NCT00054600·60 enrolled

Addition of Etanercept and Extracorporeal Photopheresis (ECP) to Standard Graft-Versus-Host Disease (GVHD) Prophylaxis in Stem Cell Transplant

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT00639717·48 enrolled

Treatment2 trials

Study of Photopheresis in the Treatment of Erythrodermic MF and SS

Withdrawn·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT03563040

The Therakos UVAR Photopheresis System in the Treatment of AIDS-Related Complex

Completed·TTherakos LLC·N/A·NCT00002011

Pilot Study1 trial

Extracorporal Photopheresis Pilot Study

Unknown status·HHospices Civils de Lyon·Phase 1/2·NCT00930566·20 enrolled

Colitis1 trial

EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis

Withdrawn·TTherakos LLC·Phase 2·NCT06646016

5 more indications

Cutaneous T-cell lymphoma1 trial

Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma

Unknown status·MMillennix·Phase 2·NCT00030589

Chronic Graft Versus Host Disease1 trial

Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease

Completed·MMallinckrodt·Phase 2·NCT00054613·72 enrolled

Rheumatoid Arthritis1 trial

Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis

Completed·MMallinckrodt·Phase 2·NCT00221000·86 enrolled

Epidermolysis Bullosa1 trial

Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa Acquisita

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004359·10 enrolled

Sezary Syndrome1 trial

Extracorporeal Photopheresis in Sezary Syndrome

Recruiting·OOleg E. Akilov, MD, PhD··NCT05157581·20 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

8-MOP

NDA NDA009048

Oct 30, 1986

OXSORALEN-ULTRA

NDA NDA019600

Feb 25, 1999

UVADEX

NDA NDA020969

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Methoxsalen. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Methoxsalen compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Methoxsalen. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020969). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Therakos, Inc., a Mallinckrodt Company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: TTherakos, Inc., a Mallinckrodt Company

8-Mop

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Trials by Indication[1]

Acute Graft Versus Host Disease2 trials

Graft Versus Host Disease2 trials

Treatment2 trials

Pilot Study1 trial

Colitis1 trial

Cutaneous T-cell lymphoma1 trial

Chronic Graft Versus Host Disease1 trial

Rheumatoid Arthritis1 trial

Epidermolysis Bullosa1 trial

Sezary Syndrome1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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