COSELA (trilaciclib dihydrochloride)
Cosela helps patients with extensive-stage small cell lung cancer by reducing the occurrence of bone marrow suppression caused by chemotherapy. It is used for adults before they receive specific chemotherapy regimens, such as topotecan or a platinum and etoposide combination. This medication helps protect the patient's blood cell counts during their cancer treatment cycle.
How COSELA Works
This drug works by temporarily blocking CDK 4 and 6, which are proteins that hematopoietic stem and progenitor cells in the bone marrow need to multiply. By inhibiting these proteins, the medication helps protect the cells that produce essential neutrophils, red blood cells, and platelets from the effects of chemotherapy.
Details
- Status
- Prescription
- First Approved
- 2021-02-12
- Patent Cliff
- 2040
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
COSELA Approval History
What COSELA Treats
2 indicationsCOSELA is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myelosuppression
- Small Cell Lung Cancer
COSELA Target & Pathway
ProTarget
COSELA 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.
What's emerging in COSELA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications COSELA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to COSELA
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
COSELA FDA Label Details
Indications & Usage
FDA Label (PDF)COSELA is indicated for the treatment of Myelosuppression; Small Cell Lung Cancer.
COSELA Patents & Exclusivity
Patents (14 active)
Exclusivity
Pro Intelligence Preview
Deep insights for COSELA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 17 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 9 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.