OHTUVAYRE (ensifentrine)
Ohtuvayre is a maintenance medication used for adults living with chronic obstructive pulmonary disease (COPD). It helps patients manage their symptoms over the long term by providing ongoing respiratory support. This therapy is prescribed to help stabilize the condition and maintain lung health in those with this chronic pulmonary issue.
How OHTUVAYRE Works
This drug works by blocking the PDE3 and PDE4 enzymes, which are responsible for breaking down messenger molecules like cAMP and cGMP. By inhibiting these enzymes, the medication causes these molecules to build up inside cells. This accumulation triggers various downstream signaling effects that provide the therapeutic benefit.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-06-26
- Patent Cliff
- 2044
- Routes
- INHALATION
- Dosage Forms
- SUSPENSION
OHTUVAYRE Approval History
What OHTUVAYRE Treats
1 indicationsOHTUVAYRE is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Obstructive Pulmonary Disease
OHTUVAYRE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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.
Drugs Similar to OHTUVAYRE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05270525 | RPL554-CO-207 | Ph 2 | recruiting | Effect of Ensifentrine on Sputum Markers of Inflammation in COPD |
| NCT05743075 | RPL554-CPC001 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease |
| NCT04535986 results posted | RPL554-CO-301 | Ph 3 | completed | A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD |
| NCT04542057 results posted | RPL554-CO-302 | Ph 3 | completed | A Phase 3 Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD |
| NCT05758428 | RPL554-AHC001 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Nebulized Ensifentrine in Healthy Chinese Subjects |
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.
OHTUVAYRE FDA Label Details
Indications & Usage
FDA Label (PDF)OHTUVAYRE is indicated for the treatment of Chronic Obstructive Pulmonary Disease.
OHTUVAYRE Patents & Exclusivity
Patents (5 active)
Exclusivity
Pro Intelligence Preview
Deep insights for OHTUVAYRE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2044
- • 5 active patents
Trial Analysis
- • 6 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • 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