Drugs / mechlorethamine
mechlorethamine
also known as
Mechlorethamine Hydrochloride · Chlormethine · Valchlor · MCH · Nitrogen Mustard · Chlorethazine · Chlormethine hcl · Chlormethine Hydrochloride · +11 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Ledaga | — | 2017-03-03 | europa.eu ↗ |
| Approved | US (FDA) | MUSTARGEN | — | 1949-03-15 | fda.gov ↗ |
Trials 16
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04026269 | Jul 2019 → Dec 2020 | classic Hodgkin lymphoma | Han weidong | Unknown | No outcome recorded |
| Phase 212 trials · 2 met primary | ||||||
| Phase 2 | NCT04218825 | Mar 2022 → Apr 2023 | mycosis fungoides | European Organisation for Research and Treatment of Cancer - EORTC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03288818 | Aug 2018 → Dec 2020 | mycosis fungoides | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT03417141 | Apr 2018 → Aug 2019 | lichen planopilaris | Mayo Clinic | Completed | Met primary |
| Phase 2 | NCT03380026 | Dec 2017 → Aug 2020 | folliculotropic mycosis fungoides, granulomatous slack skin disease, mycosis fungoides | Rochester Skin Lymphoma Medical Group, PLLC | Completed | No outcome recorded |
| Phase 2 | NCT02881749 | Sep 2016 → Aug 2020 | mycosis fungoides | Thomas Jefferson University | Unknown | No outcome recorded |
| Phase 2 | NCT00846742 | Jun 2009 → Jan 2019 overdue | Hodgkins lymphoma | St. Jude Children's Research Hospital | Active not recruiting | Met primary |
| Phase 2 | NCT00574496 | Nov 2007 → Aug 2022 | lymphoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00535470 | Jul 2007 → Mar 2011 | mycosis fungoides | Yaupon Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00003262 | May 1997 → ? | lymphoma | Centro di Riferimento Oncologico - Aviano | Unknown | No outcome recorded |
| Phase 2 | NCT00002714 | Apr 1995 → Sep 2001 | lymphoma | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT00002715 | Apr 1989 → Jan 2007 | lymphoma | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT00002463 | Feb 1989 → Jan 2007 | central nervous system neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT00041210 | Oct 2001 → ? | lymphoma | Mount Vernon Cancer Centre at Mount Vernon Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT00379041 | Sep 1993 → Oct 1998 overdue | lymphoma | European Organisation for Research and Treatment of Cancer - EORTC | Active not recruiting | Met primary |
| Phase 3 | NCT00002462 | Sep 1989 → May 2000 overdue | lymphoma | European Organisation for Research and Treatment of Cancer - EORTC | Active not recruiting | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 0 | NCT02968446 Background | Nov 2016 → Oct 2018 | dermatitis | University Hospitals Cleveland Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT06149247 Comparator | Dec 2023 → May 2024 | mycosis fungoides | Soligenix | Completed | No outcome recorded |
| Phase 2 | NCT00352027 Background | Jul 2006 → May 2015 | Hodgkins lymphoma | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00168064 Comparator | May 2006 → Aug 2010 | mycosis fungoides | Yaupon Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT00003389 Comparator | Jun 1999 → Sep 2011 | lymphoma | Eastern Cooperative Oncology Group | Completed | Missed primary |
| — | NCT05106192 Background | Apr 2022 → Jun 2025 | anaplastic large cell lymphoma, follicular lymphoma, lymphomatoid papulosis, mycosis fungoides | Case Comprehensive Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT05303480 Comparator | Dec 2021 → Dec 2022 | mycosis fungoides | Centre for Human Drug Research, Netherlands | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-04-02 | Soligenix | Results Positive Clinical Results from HyBryte™ Comparative Study Evaluating HyBryte™ Against Valchlor® in the Treatment of Cutaneous T-Cell Lymphoma Published in Oncology and Therapy soligenix.com ↗
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the positive results of its comparability study evaluating HyBryte™ (synthetic hypericin) versus Valchlor ® (mechlorethamine) for the treatment of cutaneous T-cell lymphoma (CTCL) have been published in Oncology and Therapy . |
| 2024-12-02 | Soligenix | Results HyBryte™ Clinical Results Demonstrate Continued Improvement Post-Treatment soligenix.com ↗
In contrast, of the four patients that completed the Valchlor ® arm of the study, none achieved this level of improvement by Week 16. |
| 2024-06-25 | Soligenix | Results Soligenix Announces Positive Clinical Results from a Comparative Study Evaluating HyBryte™ Against Valchlor® in the Treatment of Cutaneous T-Cell Lymphoma soligenix.com ↗
The study revealed that HyBryte™ treatment resulted in 60% of patients achieving a 50% or better improvement in their mCAILS score versus 20% of Valchlor ® patients, with HyBryte™ having a more favorable safety profile. |
All press releases naming this drug 5 releases
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mechlorethamine | “mechlorethamine hydrochloride IV on day 1 of weeks 1 and 5” NCT00846742 ↗ |
| Known as | Chlorethazine | ChEMBL registry synonym — accepted as the source's own label CHEMBL427 ↗ |
| Known as | Chlormethine | “Chlormethine Hydrochloride Injection 10mg d1,8 iv” NCT04026269 ↗ |
| Known as | Chlormethine hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL427 ↗ |
| Known as | Chlormethine Hydrochloride | “Chlormethine Hydrochloride Injection 10mg d1,8 iv” NCT04026269 ↗ |
| Known as | Chlormethini hydrochloridum | ChEMBL registry synonym — accepted as the source's own label CHEMBL427 ↗ |
| Known as | Clormetina | ChEMBL registry synonym — accepted as the source's own label CHEMBL427 ↗ |
| Known as | Ledaga | ChEMBL registry synonym — accepted as the source's own label CHEMBL427 ↗ |
| Known as | MCH | “Nitrogen Mustard (Mechlorethamine - MCH) 0.04% Formulation” NCT00535470 ↗1“mechlorethamine-MCH (nitrogen mustard)” NCT00168064 ↗ |
| Known as | Mechlorethamine hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL427 ↗ |
| Known as | Mechlorethamine Hydrochloride | “To evaluate the efficacy and safety of a novel mechlorethamine hydrochloride, 0.02%, gel in mycosis fungoides.” PMID 23069814 ↗ Jan 20133“Drug: Mechlorethamine Hydrochloride” NCT00002463 ↗ “Drug: Mechlorethamine hydrochloride” NCT00002715 ↗ |
| Known as | Mechlorethamine Hydrochloride Gel | “Mechlorethamine hydrochloride gel (Valchlor) regimen” NCT03288818 ↗ |
| Known as | Mustargen | ChEMBL registry synonym — accepted as the source's own label CHEMBL427 ↗ |
| Known as | Nitrogen Mustard | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05106192 ↗ |
| Known as | Nitrogen mustard (hn 2) | ChEMBL registry synonym — accepted as the source's own label CHEMBL427 ↗ |
| Known as | NSC-10107 | ChEMBL registry synonym — accepted as the source's own label CHEMBL427 ↗ |
| Known as | NSC-128663 | ChEMBL registry synonym — accepted as the source's own label CHEMBL427 ↗ |
| Known as | NSC-757087 | ChEMBL registry synonym — accepted as the source's own label CHEMBL427 ↗ |
| Known as | NSC-762 | “Mechlorethamine, NM, NSC-762” NCT00002462 ↗ |
| Known as | Valchlor | “Valchlor, a 0.016% gel formulation of mechlorethamine.” NCT03417141 ↗ |
| Modality | Small molecule | — CHEMBL427 ↗ |
| Route | Intravenous | “mechlorethamine IV and vincristine IV on days 1 and 8” NCT00002463 ↗ |