Drugs / Methoxsalen
Methoxsalen
also known as
UVADEX · 8-MOP · 8-methoxsalen · 8-methoxypsoralen · Deltasoralen · Meladinine · METHOXSALEN COMPONENT OF SM-88 · Metoxalen · +7 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | 8-MOP | — | 1988-03-23 | fda.gov ↗ |
| Approved | US (FDA) | 8-MOP | — | 1954-12-03 | fda.gov ↗ |
Trials 21 · a red edge is where a trial was stopped
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01380535 | Nov 2011 → Mar 2015 | chronic graft versus host disease | Mallinckrodt | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT04389281 | Dec 2021 → Sep 2028 expected | — | Immunolight, LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT00056355 | Mar 2003 → Nov 2005 | Crohn disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00930566 | Apr 2009 → Sep 2011 | hematopoietic and lymphoid cell neoplasm | Hospices Civils de Lyon | Unknown | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT07619898 | Jul 2026 → Dec 2028 expected | colitis, hepatitis, melanoma | Therakos | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06646016 | Dec 2025 → Feb 2026 | colitis | Therakos | Withdrawn | No outcome recorded |
| Phase 2 | NCT04986605 | Jul 2025 → Jul 2026 overdue | diffuse cutaneous systemic sclerosis | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06133192 | Jan 2024 → Sep 2025 | graft versus host disease | Central Hospital, Nancy, France | Unknown | No outcome recorded |
| Phase 2 | NCT05680558 | May 2021 → Mar 2027 expected | mycosis fungoides | Columbia University | Recruiting | No outcome recorded |
| Phase 2 | NCT03563040 | Dec 2020 → Sep 2022 | mycosis fungoides and variants | European Organisation for Research and Treatment of Cancer - EORTC | Withdrawn | No outcome recorded |
| Phase 2 | NCT04291261 | May 2020 → Jun 2024 overdue | acute graft versus host disease | University Medical Center Hamburg-Eppendorf | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03778996 | Jan 2020 → Dec 2027 expected | Ewing sarcoma | Sarcoma Oncology Research Center, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00639717 | Mar 2009 → Jan 2012 | graft versus host disease | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00221026 | Dec 2004 → Jun 2006 | Crohn disease | Mallinckrodt | Completed | No outcome recorded |
| Phase 2 | NCT00054613 | Jun 2002 → Mar 2004 | chronic graft versus host disease | Mallinckrodt | Completed | No outcome recorded |
| Phase 2 | NCT00054600 | Jun 2002 → Jun 2004 | graft versus host disease | Mallinckrodt | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02524847 | Jan 2016 → Jul 2019 | acute graft versus host disease | Therakos, Inc., a Mallinckrodt Company | Terminated | No outcome recorded |
| Phase 3 | NCT00282503 | Jan 2006 → Jun 2007 | acute graft versus host disease | Mallinckrodt | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00221039 | Apr 2004 → Apr 2011 | mycosis fungoides | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00002011 | — | HIV infectious disease | Therakos | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06836648 | — | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Available | No outcome recorded |
Also used as a comparator or background therapy in 11 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02796898 Background | Jun 2016 → May 2019 | prostate cancer | Tyme, Inc | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT04720664 Background | Sep 2021 → Feb 2023 | hormone receptor-positive breast cancer | Georgetown University | Terminated | No outcome recorded |
| Phase 2 | NCT03605940 Background | Oct 2018 → Apr 2021 | acute graft versus host disease | Central Hospital, Nancy, France | Unknown | No outcome recorded |
| Phase 2 | NCT02322190 Background | Dec 2014 → Oct 2019 | chronic graft versus host disease | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT00221000 Background | Aug 2003 → Oct 2006 | rheumatoid arthritis | Mallinckrodt | Completed | No outcome recorded |
| Phase 2 | NCT00030589 Background | Feb 2001 → ? | lymphoma | Millennix | Unknown | No outcome recorded |
| Phase 2 | NCT00004359 Background | Feb 1996 → ? | acquired epidermolysis bullosa | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03512756 Background | Mar 2018 → Dec 2021 | malignant pancreatic neoplasm | Tyme, Inc | Terminated | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02181257 Background | Jan 2015 → Apr 2027 expected | bronchiolitis obliterans syndrome | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01686594 Comparator | Feb 2013 → Jul 2018 | mycosis fungoides | Medical University of Graz | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00630903 Comparator | Jan 2000 → Jan 2003 | mycosis fungoides | Madrilenian Group of Cutaneous Lymphomas | Terminated | No outcome recorded |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | methoxsalen | “Patients will receive the recommended phase 2 dose (RP2D) of SM-88 (460 mg by mouth [PO] twice a day [BID] D1 - 28) as well as three conditioning agents (MPS): methoxsalen (10...” NCT04720664 ↗26“The phase II aspect of the study refers to the drug, methoxsalen. Methoxsalen is being used off label from the currently approved indications in the monograph.” NCT04986605 ↗ “Racemetyrosine (SM-88) is an amino-acid analogue used with methoxsalen, phenytoin, and sirolimus (MPS) to enhance SM-88 activity.” PMID 32924093 ↗ Sep 2020 “X-PACT is comprised of a phosphor device, the drug methoxsalen sterile solution and X-ray energy.” NCT04389281 ↗ “Methoxsalen is a psoralen found in the seeds of the Ammi majus (Umbelliferae) plant.” NCT06836648 ↗ “Both systems use the drug Methoxsalen” NCT02181257 ↗ |
| Known as | 8-methoxsalen | “Treatment involves the patient ingesting 8-methoxsalen (8-MOP) by mouth approximately two hours prior to each photopheresis session.” NCT00002011 ↗ |
| Known as | 8-methoxypsoralen | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01686594 ↗ |
| Known as | 8-MOP | “methoxsalen (whether formulated as the sterile solution [Uvadex®] or as a hard gelatin capsule [8-MOP®]) can promote a strong long-term clinical response” NCT06836648 ↗4“Treatment involves the patient ingesting 8-methoxsalen (8-MOP) by mouth approximately two hours prior to each photopheresis session.” NCT00002011 ↗ “Oral methoxsalen (8-MOP) is administered 90 minutes prior to leukapheresis.” NCT00004359 ↗ “PUVA (8MOP + UVA) + IFN” NCT00630903 ↗ |
| Known as | Deltasoralen | ChEMBL registry synonym — accepted as the source's own label CHEMBL416 ↗ |
| Known as | Meladinine | ChEMBL registry synonym — accepted as the source's own label CHEMBL416 ↗ |
| Known as | METHOXSALEN COMPONENT OF SM-88 | ChEMBL registry synonym — accepted as the source's own label CHEMBL416 ↗ |
| Known as | Metoxalen | ChEMBL registry synonym — accepted as the source's own label CHEMBL416 ↗ |
| Known as | NSC-45923 | ChEMBL registry synonym — accepted as the source's own label CHEMBL416 ↗ |
| Known as | Oxsoralen | ChEMBL registry synonym — accepted as the source's own label CHEMBL416 ↗ |
| Known as | Oxsoralen-ultra | ChEMBL registry synonym — accepted as the source's own label CHEMBL416 ↗ |
| Known as | Oxypsoralen | ChEMBL registry synonym — accepted as the source's own label CHEMBL416 ↗ |
| Known as | Puvalen | ChEMBL registry synonym — accepted as the source's own label CHEMBL416 ↗ |
| Known as | Puvasoralen-8 | ChEMBL registry synonym — accepted as the source's own label CHEMBL416 ↗ |
| Known as | UVADEX | “methoxsalen (whether formulated as the sterile solution [Uvadex®] or as a hard gelatin capsule [8-MOP®]) can promote a strong long-term clinical response” NCT06836648 ↗5“UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis” NCT05680558 ↗ “photoactivatable compound (UVADEX)” NCT00054600 ↗ |
| Known as | Vitpso | ChEMBL registry synonym — accepted as the source's own label CHEMBL416 ↗ |
| Modality | Other / unclassified | “photoactivatable compound (UVADEX)” NCT00054600 ↗ |
| Route | Oral | “ingesting 8-methoxsalen (8-MOP) by mouth” NCT00002011 ↗ |