GUANFACINE HYDROCHLORIDE
GUANFACINE HYDROCHLORIDE is indicated for the treatment of Hypertension.
Details
- Status
- Prescription
- First Approved
- 1995-10-17
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET
Companies
GUANFACINE HYDROCHLORIDE Approval History
What GUANFACINE HYDROCHLORIDE Treats
1 indicationsGUANFACINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
GUANFACINE 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.
What's emerging in GUANFACINE HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications GUANFACINE HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to GUANFACINE HYDROCHLORIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02141113 ADINT2012 results posted | 1129704 ADINT | Ph 4 | completed | Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65). |
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.
GUANFACINE HYDROCHLORIDE FDA Label Details
Indications & Usage
GUANFACINE HYDROCHLORIDE is indicated for the treatment of Hypertension.
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Full clinical data, patents, trials, and competitive landscape for guanfacine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.