MINOLIRA (minocycline hydrochloride)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2017-05-08
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
MINOLIRA Approval History
What MINOLIRA Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
Other
(1 approval)- • Approved indication (May 2017)
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06246396 | IRB202301939 2R01HL132448-05A1 | Ph 4 | recruiting | Antihypertensive Mechanisms of Minocycline in Resistant Hypertension |
| NCT05826912 APT-TBI-01 | APT-TBI-01 | Ph 2 | enrolling by invitation | Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury |
| NCT02203552 results posted | OSU-13165 NCI-2014-00851 | Ph 2 | completed | Minocycline Hydrochloride in Reducing Chemotherapy Induced Depression and Anxiety in Patients With Stage I-III Breast Cancer |
| NCT02297412 results posted | RU221408I NCI-2016-01592, RU221408I | Ph 2 | completed | Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel |
| NCT04076098 | RP139-02/18 | Ph 4 | completed | Locally Delivered Minocycline in Advanced Periodontitis |
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.
MINOLIRA FDA Label Details
MINOLIRA Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for MINOLIRA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 4 active patents
Trial Analysis
- • 5 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment