Data updated: May 30, 2026
CYMBALTA (duloxetine hydrochloride)
Trial Activity: Declining
CNS
Approved 2004-08-03
Development Insights
Dr. Reddy's Laboratories Limited conducting 2 trials (50%)
5 indications explored (Moderate)
→ healthy (2 trials)
→ painful diabetic peripheral neuropathy (pdpn) (1 trials)
→ joint disease (1 trials)
10
Indications
--
Phase 3 Trials
2
Priority Reviews
21
Years on Market
Details
- Status
- Prescription
- First Approved
- 2004-08-03
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED REL PELLETS
CYMBALTA Approval History
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
123 FDA actions from 2004 to 2023 · 4 indication expansions
Jul 2016 SUPPL
Mfg
What CYMBALTA Treats
10 FDA approvalsOriginally approved for its first indication in 2004 . Covers 10 distinct patient populations.
- Other (10)
Other
(10 approvals)- • Approved indication (Aug 2004)Label Letter
- • Approved indication (Sep 2004) PriorityLabel Letter
- • Approved indication (Feb 2007)Label Letter
- • Approved indication (Nov 2007)Label Letter
- • Approved indication (Jun 2008)Label Letter
- • Approved indication (Nov 2009)Label Letter
- • Approved indication (Nov 2010)Label Letter
- • Approved indication (Oct 2012) PriorityLabel Letter
- • Approved indication (Oct 2014)Label Letter
- • Approved indication (Apr 2020)Label Letter
Eli Lilly's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
INLURIYO
2025 IMLUNESTRANT TOSYLATE
1 designation
KISUNLA
2024 DONANEMAB-AZBT
3 designations
EBGLYSS
2024 LEBRIKIZUMAB-LBKZ
1 designation
OMVOH
2023 MIRIKIZUMAB-MRKZ
MOUNJARO
2022 TIRZEPATIDE
1 designation
RETEVMO
2020 SELPERCATINIB
4 designations
REYVOW
2019 LASMIDITAN SUCCINATE
1 designation
EMGALITY
2018 GALCANEZUMAB-GNLM
1 designation
OLUMIANT
2018 BARICITINIB
VERZENIO
2017 ABEMACICLIB
2 designations
LARTRUVO
2016 OLARATUMAB
4 designations
TALTZ
2016 IXEKIZUMAB
📋
Clinical Trial Registry
10 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 |
| NCT03271151 results posted | 2017-0655 | Ph 4 | completed | Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty |
| 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 |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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.
CYMBALTA FDA Label Details
Track CYMBALTA with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
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