Wednesday, July 8, 2026

Drug profile · INN

duloxetine hydrochloride

duloxetine hydrochloride (CYMBALTA PARTIAL CHANGE APPROVAL) is a norepinephrine transporter inhibitor. Associated with Sunshine Guojian Pharmaceutical (Shanghai) Co.,. Route of administration: oral. Current US regulatory status: approved.

FDA: approved PMDA: approved
US status approved
Patents linked 20
Pipeline programs 3
News articles 0
Drug details — duloxetine hydrochloride
US status
approved
Class
Route
ORAL
Patents
20
Programs
3
Data quality
0.89

Quick answer

duloxetine hydrochloride (CYMBALTA PARTIAL CHANGE APPROVAL) is a norepinephrine transporter inhibitor. Associated with Sunshine Guojian Pharmaceutical (Shanghai) Co.,. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN duloxetine hydrochloride
Brand CYMBALTA PARTIAL CHANGE APPROVAL
Mechanism Norepinephrine transporter inhibitor
Target Sodium-dependent noradrenaline transporter
Route ORAL
Formulation CAPSULE, DELAYED RELEASE

Mechanism of action

Norepinephrine transporter inhibitor

Primary target: Sodium-dependent noradrenaline transporter

Approval history

Authority Status Date
FDA approved
PMDA approved

Pipeline programs

  1. Duloxetine Phase 3 · Pacira Ireland · Knee Osteoarthritis
  2. Duloxetine hydrochloride Phase 3 · Eli Lilly and · Diabetic Neuropathies
  3. Cymbalta hard gastro-resistant capsules for chemotherapy-induced neuropathi… Approved · Disc Medicine · chemotherapy-induced neuropathic pain

Related & competitor drugs

  1. amitriptyline hydrochloride Norepinephrine transporter inhibitor
  2. atomoxetine hydrochloride Norepinephrine transporter inhibitor
  3. desipramine hydrochloride Norepinephrine transporter inhibitor
  4. desvenlafaxine fumarate Norepinephrine transporter inhibitor
  5. doxepin hydrochloride Norepinephrine transporter inhibitor
  6. imipramine hydrochloride Serotonin transporter inhibitor
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Frequently asked questions

What is duloxetine hydrochloride?

duloxetine hydrochloride (CYMBALTA PARTIAL CHANGE APPROVAL) is a norepinephrine transporter inhibitor. Associated with Sunshine Guojian Pharmaceutical (Shanghai) Co.,. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for duloxetine hydrochloride?

CYMBALTA PARTIAL CHANGE APPROVAL is a marketed brand name for duloxetine hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of duloxetine hydrochloride?

duloxetine hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.