MIDODRINE HYDROCHLORIDE
MIDODRINE HYDROCHLORIDE is indicated for the treatment of Orthostatic Hypotension.
Details
- Status
- Prescription
- First Approved
- 2003-09-10
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
MIDODRINE HYDROCHLORIDE Approval History
What MIDODRINE HYDROCHLORIDE Treats
1 indicationsMIDODRINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Orthostatic Hypotension
MIDODRINE HYDROCHLORIDE Boxed Warning
Because midodrine can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of midodrine in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, howev...
Warning: Because midodrine can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of midodrine in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine, principally improved ability to carry out activities of daily living, have not been verified.
MIDODRINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03706053 results posted | 20889 | Ph 3 | terminated | Midodrine Use in Septic Shock |
| NCT02379156 results posted | HAN-14-045 315696, 01589 | Ph 4 | completed | Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia |
| NCT02919917 results posted | WEC-16-050 | Ph 2, Ph 3 | completed | Treatment of Post-SCI Hypotension |
| NCT05839652 SCI | 1747301-1 | Ph 4 | recruiting | Treatment of Orthostatic Hypotension in SCI |
| NCT02893553 results posted | WEC-16-015 | Ph 2 | completed | The Effects of Normalizing Blood Pressure on Cerebral Blood Flow in Hypotensive Individuals With Spinal Cord Injury |
| NCT01456481 POST 4 | CIHR#243314 | Ph 4 | active not recruiting | Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV |
| NCT05240391 | AIGHEPAT007 | Ph 3 | completed | Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance |
| NCT01822535 results posted | 01374 | Ph 4 | completed | Body Temperature in Persons With Tetraplegia When Exposed to Cold |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MIDODRINE HYDROCHLORIDE FDA Label Details
Indications & Usage
MIDODRINE HYDROCHLORIDE is indicated for the treatment of Orthostatic Hypotension.
Warning: Because midodrine can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of midodrine in the treatment of symptomatic orthostatic hypotension is based primarily on a chan...
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ORVATEN
Full clinical data, patents, trials, and competitive landscape for midodrine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.