DRIZALMA SPRINKLE (duloxetine hydrochloride)
DRIZALMA SPRINKLE is indicated for the treatment of Major Depressive Disorder; Generalized Anxiety Disorder; Diabetic Peripheral Neuropathy; Fibromyalgia; Chronic Musculoskeletal Pain.
How DRIZALMA SPRINKLE Works
Duloxetine hydrochloride functions as a serotonin and norepinephrine reuptake inhibitor (SNRI). While the precise mechanisms for its antidepressant, anxiolytic, and central pain inhibitory effects are not fully established, they are attributed to the drug's ability to enhance activity within the central nervous system. Specifically, the medication works by potentiating serotonergic and noradrenergic activity.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-07-19
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED REL PELLETS
DRIZALMA SPRINKLE Approval History
What DRIZALMA SPRINKLE Treats
5 indicationsDRIZALMA SPRINKLE is approved for 5 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Diabetic Peripheral Neuropathy
- Fibromyalgia
- Chronic Musculoskeletal Pain
DRIZALMA SPRINKLE Boxed Warning
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Increased risk of suicidal thinking and behavior in pediatric and ...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Increased risk of suicidal thinking and behavior in pediatric and young adult patients taking antidepressants (5.1) • Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors (5.1)
DRIZALMA SPRINKLE 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.
Drugs Similar to DRIZALMA SPRINKLE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04137107 | A221805 NCI-2019-04727 | Ph 2, Ph 3 | active not recruiting | Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer |
| NCT01598298 results posted | S1202 S1202, U10CA037429 | Ph 3 | completed | S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy |
| NCT03395353 results posted | 16916 F1J-JE-HMHF, 1702A3632 | Ph 3 | terminated | A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder |
| NCT03315793 results posted | 14937 F1J-JE-B058, 1701A3631 | Ph 3 | completed | A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder |
| NCT00489411 results posted | CALGB-170601 CALGB-170601, CDR0000553389 | Ph 3 | completed | Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer |
| NCT00960986 results posted | 9884 F1J-MC-HMFL | Ph 4 | completed | A Duloxetine Dosing Strategy Study in Korean Patients With Major Depressive Disorder |
| NCT00810069 results posted | 12329 F1J-EW-HMGD | Ph 4 | completed | Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder |
| NCT00641719 results posted | 12194 F1J-JE-HMFY | Ph 3 | completed | A Long-term Study for the Treatment of Painful Diabetic Neuropathy |
| NCT00673452 results posted | 12220 F1J-US-HMGB | Ph 4 | completed | A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia |
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.
DRIZALMA SPRINKLE FDA Label Details
Indications & Usage
FDA Label (PDF)DRIZALMA SPRINKLE is indicated for the treatment of Major Depressive Disorder; Generalized Anxiety Disorder; Diabetic Peripheral Neuropathy; Fibromyalgia; Chronic Musculoskeletal Pain.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors ...
DRIZALMA SPRINKLE Patents & Exclusivity
Patents (5 active)
Pro Intelligence Preview
Deep insights for DRIZALMA SPRINKLE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 80 active patents
Trial Analysis
- • 10 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