CINQAIR (reslizumab)
CINQAIR (reslizumab) is an interleukin-5 antagonist monoclonal antibody indicated for the add-on maintenance treatment of severe asthma. It is specifically approved for adult patients aged 18 years and older who present with an eosinophilic phenotype. The medication is not intended for the treatment of other eosinophilic conditions or for the relief of acute respiratory symptoms such as bronchosp
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-03-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CINQAIR Approval History
What CINQAIR Treats
1 indicationsCINQAIR is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
CINQAIR Boxed Warning
ANAPHYLAXIS Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after CINQAIR administration by a healthcare professional prepared to manage anaphylaxis. Discontinue CINQAIR immediately if the patient experience...
WARNING: ANAPHYLAXIS Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after CINQAIR administration by a healthcare professional prepared to manage anaphylaxis. Discontinue CINQAIR immediately if the patient experiences signs or symptoms of anaphylaxis [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 )] . WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis occurred with CINQAIR infusion in 0.3% of patients in placebo-controlled studies ( 5.1 ) Patients should be observed for an appropriate period of time after CINQAIR infusion; healthcare professionals should be prepared to manage anaphylaxis that can be life-threatening ( 5.1 ) Discontinue CINQAIR immediately if the patient experiences anaphylaxis ( 5.1 )
CINQAIR Target & Pathway
ProTarget
CINQAIR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04183192 results posted | SCR-006 | Ph 1 | completed | Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists |
| NCT04710134 | RES-2020-20 | Ph 4 | completed | Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma |
| NCT03052725 results posted | C38072-AS-30066 2016-004661-23 | Ph 3 | terminated | A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma |
| NCT01111305 results posted | 10-I-0101 100101 | Ph 2 | completed | Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis |
| NCT01287039 results posted | C38072/3082 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma |
| NCT02937168 DEAR results posted | C38072-AS-40105 | Ph 4 | terminated | An Imaging Study Using PET/CT to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation |
| NCT02501629 results posted | C38072-AS-30027 2015-001580-39 | Ph 3 | completed | An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils |
| NCT02452190 results posted | C38072-AS-30025 2015-000865-29 | Ph 3 | completed | Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils |
| NCT01285323 results posted | C38072/3083 2010-024006-35 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma |
| NCT03074942 | SEP-RES-2016-01 | Ph 2 | completed | Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab |
| NCT02559791 | RES-38072 | Ph 2, Ph 3 | completed | Anti-Interleukin-5 (IL5) Monoclonal Antibody (MAb) in Prednisone-dependent Eosinophilic Asthma |
| NCT02947945 RITE | HS-3025 | Ph 2 | recruiting | Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study |
| NCT00635089 results posted | Res-5-0004 | Ph 3 | completed | Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis |
| NCT00538434 results posted | Res-05-0002 | Ph 2, Ph 3 | completed | Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years |
| NCT00587288 results posted | Res-5-0010 | Ph 2 | completed | Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma |
| NCT01508936 results posted | C38072/3084 | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma |
| NCT01270464 results posted | C38072/3081 2010-023342-67 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma |
| NCT01290887 results posted | C38072/3085 2010-024540-15 | Ph 3 | terminated | Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma |
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.
CINQAIR FDA Label Details
Indications & Usage
FDA Label (PDF)CINQAIR is indicated for the treatment of Asthma.
WARNING: ANAPHYLAXIS Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Anaphylaxis can be life-threatening. ...
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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