Drugs / Lofexidine
Lofexidine
also known as
Lofexidine HCl · Lucemyra · Lofexidine hydrochloride · Britlofex · Lofexidina · Lofexidine Hydrochloride (HCl) · LX2 · MDL 14,042 · +1 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | LUCEMYRA | — | 2018-05-16 | fda.gov ↗ |
Trials 29 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT06711640 | Jun 2025 → Jan 2026 | opiate dependence, substance withdrawal syndrome | USWM, LLC (dba US WorldMeds) | Withdrawn | No outcome recorded |
| Phase 1 | NCT04188730 | Feb → Mar 2021 | — | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 1 | NCT02801357 | Jun → Aug 2016 | opiate dependence, substance withdrawal syndrome | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 1 | NCT02681198 | Jan → Mar 2016 | — | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 1 | NCT02446002 | May → Jun 2015 | — | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 1 | NCT02313103 | Nov 2014 → Feb 2015 | — | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 1 | NCT01629446 | May → Jun 2012 | — | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 1 | NCT01558934 | Feb → Apr 2012 | opiate dependence, substance withdrawal syndrome | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 1 | NCT01437306 | Oct 2011 | — | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 1 | NCT01310296 | Jul → Aug 2011 | — | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 1 | NCT00218530 | Mar 2003 → Sep 2004 | heroin dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00000354 | Jul 1996 → Sep 1997 | opiate dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00000345 | Apr 1996 → ? | opiate dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00000358 | — | opiate dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05712707 | Feb 2023 → Jun 2025 overdue | substance withdrawal syndrome | New York State Psychiatric Institute | Active not recruiting | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT06047834 | Oct 2023 → May 2025 overdue | substance withdrawal syndrome | BioCorRx Pharmaceuticals Inc | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05027919 | Dec 2021 → Nov 2026 expected | opiate dependence, substance withdrawal syndrome | University of Maryland, Baltimore | Recruiting | No outcome recorded |
| Phase 2 | NCT04360681 | Mar 2021 → Dec 2025 | opiate dependence, post-traumatic stress disorder | Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | Completed | No outcome recorded |
| Phase 2 | NCT04056182 | Sep 2019 → Jan 2021 | substance-related disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2 | NCT04070157 | Aug → Nov 2019 | substance withdrawal syndrome | USWM, LLC (dba US WorldMeds) | Terminated | No outcome recorded |
| Phase 2 | NCT03718065 | Jun 2019 → Jan 2024 | opiate dependence | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 2 | NCT00373503 | Aug 2005 → Jun 2007 | cannabis dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2 | NCT00142909 | Feb 2005 → Jan 2009 | opiate dependence | Yale University | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01020019 | Jan 2010 → Sep 2014 | cannabis dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02363998 | Feb → Sep 2015 | substance withdrawal syndrome | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 3 | NCT00235729 | Jun 2006 → Oct 2007 | opiate dependence | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 3 | NCT00032942 | Apr 2001 → Oct 2004 | opiate dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04126083 | Sep 2019 → Apr 2021 | substance withdrawal syndrome | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT01675648 | Aug 2012 → Jul 2015 | — | Institute of Mental Health, Singapore | Completed | No outcome recorded |
Also used as a comparator or background therapy in 11 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT02318836 Comparator | Jun → Oct 2014 | liver failure | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 1 | NCT01820442 Comparator | Mar → Sep 2013 | opiate dependence, substance withdrawal syndrome | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 1 | NCT01650649 Comparator | Jul → Dec 2012 | opiate dependence, substance withdrawal syndrome | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 1 | NCT01148992 Comparator | Aug → Dec 2010 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Terminated | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05995535 Background | Jan 2024 → Aug 2026 overdue | substance withdrawal syndrome | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 2 | NCT05511909 Comparator | Mar 2023 → Jan 2027 expected | anxiety, opiate dependence, substance withdrawal syndrome | University of Maryland, Baltimore | Recruiting | No outcome recorded |
| Phase 2 | NCT04218240 Background | Dec 2020 → Aug 2023 | substance withdrawal syndrome | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04325659 Comparator | Nov 2020 → Apr 2025 | opiate dependence, substance abuse, substance withdrawal syndrome | Johns Hopkins University | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01863186 Comparator | Jun 2013 → Nov 2014 | opiate dependence, substance withdrawal syndrome | USWM, LLC (dba US WorldMeds) | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05569031 Comparator | Jan 2019 → Dec 2021 | substance withdrawal syndrome | Zagazig University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05053503 Comparator | May 2022 → Apr 2025 | opiate dependence, substance withdrawal syndrome | Spark Biomedical, Inc. | Completed | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lofexidine | “Lofexidine is currently approved in the U.S. for the mitigation of withdrawal symptoms during discontinuation from use of opioids under the brand name Lucemyra.” NCT05712707 ↗39“lofexidine tablets 0.18mg tabs” NCT05995535 ↗ |
| Known as | Britlofex | ChEMBL registry synonym — accepted as the source's own label CHEMBL17860 ↗ |
| Known as | Lofexidina | ChEMBL registry synonym — accepted as the source's own label CHEMBL17860 ↗ |
| Known as | Lofexidine HCl | “Lofexidine HCl tablets (two 200 µg tablets) will be administered orally with 240 mL room temperature tap water as a single 400 µg dose in the morning on Day 1 after a 10 hour...” NCT02318836 ↗5“Lofexidine HCl 0.2 mg tablets titrated in ascending doses of 0.2 mg QID (e.g. Day 1 0.2 mg QID, Day 2 0.4 QID, etc)as described in the treatment arm.” NCT01558934 ↗ “Lofexidine HCl is an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids.” NCT02681198 ↗ “Single Dose = Solution containing 400 μg lofexidine HCl and a tracer amount of 14C lofexidine” NCT01629446 ↗ “Lofexidine HCl tablets will be available in 0.2 mg tablets.” NCT01863186 ↗ “Drug: Lofexidine HCl” NCT01437306 ↗ |
| Known as | Lofexidine hydrochloride | “The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute...” NCT01863186 ↗ |
| Known as | Lofexidine Hydrochloride (HCl) | “Lofexidine Hydrochloride (HCl) tablets” NCT02318836 ↗ |
| Known as | Lucemyra | “The aim of this clinical trial is to evaluate the efficacy of Lucemyra™ (lofexidine; LFX), an alpha-2-adrenergic receptor (α2-AR) agonist, as a medication for the prevention of...” NCT04360681 ↗5“Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical...” NCT03718065 ↗ “Lofexidine is currently approved in the U.S. for the mitigation of withdrawal symptoms during discontinuation from use of opioids under the brand name Lucemyra.” NCT05712707 ↗ “Lofexidine (Lucemyra) encapsulated” NCT04325659 ↗ “LUCEMYRA (lofexidine) tablets” NCT04188730 ↗ “LUCEMYRA (lofexidine) tablets” NCT06711640 ↗ |
| Known as | LX2 | “Drug: Lofexidine (LX2) All participants will receive standard of care and 32 µg/kg/day of Lofexidine, administered as 4 µg/kg/day every 3 hours.” NCT06047834 ↗ |
| Known as | MDL 14,042 | ChEMBL registry synonym — accepted as the source's own label CHEMBL17860 ↗ |
| Known as | NSC-759654 | ChEMBL registry synonym — accepted as the source's own label CHEMBL17860 ↗ |
| Action | Activate | “Lofexidine is an alpha2-adrenergic-agonist” NCT00235729 ↗ |
| Modality | Small molecule | — CHEMBL17860 ↗ |
| Route | Oral | “Lofexidine or placebo will be administered orally within 15 minutes before or after 0800, 1300, 1800 and 2300 hours on Days 1-5.” NCT00235729 ↗ |