Droxidopa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | NORTHERA | — | 2014-02-18 | fda.gov ↗ |
Trials 32 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01149629 Comparator | Jul → Aug 2010 | orthostatic hypotension | Chelsea Therapeutics | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04977388 Comparator | Jul 2021 → Oct 2023 | Menkes disease, occipital horn syndrome | Stephen G. Kaler, MD | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT02812147 Comparator | May 2016 → Jun 2019 | Parkinson disease | St. Joseph's Hospital and Medical Center, Phoenix | Unknown | No outcome recorded |
| Phase 2 | NCT02558972 Comparator | Sep 2015 → Dec 2022 | postural orthostatic tachycardia syndrome, syncope, familial vasovagal | New York Medical College | Terminated | No outcome recorded |
| Phase 2 | NCT00657046 Comparator | Dec 2007 → Jan 2009 | — | Chelsea Therapeutics | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT01927055 Comparator | Nov 2013 → Feb 2015 | Parkinson disease, disorder of catecholamine synthesis, orthostatic hypotension, pure autonomic failure | Chelsea Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT00782340 Comparator | Sep 2008 → Sep 2010 | disorder of catecholamine synthesis, orthostatic hypotension, peripheral neuropathy, primary dysautonomia | Chelsea Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT00738062 Comparator | Jan 2008 → Dec 2010 | autonomic neuropathy, disorder of catecholamine synthesis, multiple system atrophy, orthostatic hypotension | Chelsea Therapeutics | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03034564 Comparator | Jan 2017 → Sep 2018 | Parkinson disease | The Cooper Health System | Terminated | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Droxidopa | “Twenty-five participants will be asked to visit the laboratory on 6 occasions, for an open-label, dose escalation trial to determine the effect of midodrine and droxidopa on...” NCT05839652 ↗36 |
| Known as | DOPS | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103827 ↗ |
| Known as | L-DOPS | “Droxidopa \[also, known as L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS\] is the International non-proprietary name (INN) for a synthetic amino acid precursor of...” NCT00782340 ↗4“Droxidopa [also, known as L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS] is the International non-proprietary name (INN) for a synthetic amino acid precursor of...” NCT00738062 ↗ “Introduction Droxidopa (L-DOPS) is an orally administered, synthetic catecholamine” NCT01468259 ↗ “Droxidopa (L-DOPS)” NCT02624310 ↗ |
| Known as | L-threo-3,4-dihydroxyphenylserine | “Droxidopa \[also, known as L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS\] is the International non-proprietary name (INN) for a synthetic amino acid precursor of...” NCT00782340 ↗3“Droxidopa [also, known as L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS] is the International non-proprietary name (INN) for a synthetic amino acid precursor of...” NCT00738062 ↗ “The drug Droxidopa is a synthetic amino acid L-threo-3,4-dihydroxyphenylserine and can be metabolized by the non-copper dependent enzyme DOPA decarboxylase to produce...” NCT07398508 ↗ “droxidopa [also, known as L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS] is the International non-proprietary name (INN) for a synthetic amino acid precursor of...” NCT00633880 ↗ |
| Known as | L-threo-DOPS | “Droxidopa \[also, known as L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS\] is the International non-proprietary name (INN) for a synthetic amino acid precursor of...” NCT00782340 ↗2“Droxidopa [also, known as L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS] is the International non-proprietary name (INN) for a synthetic amino acid precursor of...” NCT00738062 ↗ |
| Known as | Northera | “Droxidopa (Northera) is an approved drug for the treatment of low blood pressure in PD.” NCT03115827 ↗ |
| Action | Activate | “direct alpha-1 adrenoreceptor agonist” NCT03070730 ↗ |
| Modality | Small molecule | “a synthetic amino acid precursor of norepinephrine (NE)” NCT00738062 ↗ |
| Route | Oral | “Droxidopa Oral Product” NCT00581477 ↗ |