Droxidopa
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed primary orthostatic hypotension 1 milestone | |||||
| Filed | US (FDA) | — | primary orthostatic hypotension | — | “for the treatment of neurogenic orthostatic hypotension and resubmitted an application for FDA approval in August 2013.” sumitomo-pharma.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | NORTHERA | — | 2014-02-18 | fda.gov ↗ |
Trials 32
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2021-09-28 | Lupin Limited | Regulatory Lupin Launches Droxidopa Capsules in the United States lupin.com ↗
Global pharma major Lupin Limited (Lupin) today announced the launch of Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, having received an approval from the United States Food and Drug Administration (US FDA). |
| 2021-02-19 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives final approval from USFDA for Droxidopa Capsules zyduslife.com ↗
Zydus Cadila has received final approval from the USFDA to market Droxidopa Capsules, 100 mg, 200 mg, and 300 mg (US RLD: Northera Capsules). |
| 2021-02-19 | Lupin Limited | Regulatory Lupin Receives Approval for Droxidopa Capsules lupin.com ↗
today announced that it has received approval for its Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, from the United States Food and Drug Administration |
| 2020-05-16 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives tentative approval from USFDA for Droxidopa Capsules, 100 mg, 200 mg, and 300 mg zyduslife.com ↗
Zydus Cadila has received tentative approval from the USFDA to market Droxidopa Capsules, (US RLD: Northera®) in the strengths of 100 mg, 200 mg, and 300 mg. |
| 2014-02-19 | Sumitomo Pharma America, Inc. | Regulatory Chelsea Therapeutics Obtains US FDA Accelerated Approval on "NORTHERA" sumitomo-pharma.com ↗
obtained the U.S. Food and Drug Administration (FDA) accelerated approval on the agent on February 18, 2014 (U.S. time) for the treatment of neurogenic orthostatic hypotension. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-09-28 | Lupin Limited | Lupin Launches Droxidopa Capsules in the United States lupin.com ↗ |
| 2021-02-19 | Zydus Lifesciences Limited | Zydus Cadila receives final approval from USFDA for Droxidopa Capsules zyduslife.com ↗ |
| 2021-02-19 | Lupin Limited | Lupin Receives Approval for Droxidopa Capsules lupin.com ↗ |
| 2020-05-16 | Zydus Lifesciences Limited | Zydus Cadila receives tentative approval from USFDA for Droxidopa Capsules, 100 mg, 200 mg, and 300 mg zyduslife.com ↗ |
| 2014-02-19 | Sumitomo Pharma America, Inc. | Chelsea Therapeutics Obtains US FDA Accelerated Approval on "NORTHERA" sumitomo-pharma.com ↗ |
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 ↗ |
| 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 ↗ |