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Desipramine

Phase 4

Depression | Small molecule | Psychiatry |Novartis AG|Trials Updated: Mar 28, 2017

Desipramine development status

Highest phase Phase 4 run by Harvard Medical School (HMS and HSDM) (NCT00320632)
Phase scored for NVSPhase 1
Registered trials 5 across 3 sponsors since May 2006

Desipramine target and mechanism

Molecular targetSLC6A2
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL72

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment72

FDA Designations

No designations recorded

Desipramine clinical trials

Desipramine · 2 trials · 1 indication

Phase 1 2
NCT00913822To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride TabletsDepression
COMPLETED36 Analytics
NCT00913237To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg TabletsDepression
COMPLETED36 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets
DepressionUnlock trial analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets
DepressionUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
22 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDesipramine Hydrochloride 100 mg Tablets (Cord Laboratories)
2ACTIVE_COMPARATORNorpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)

Interventions

NameTypeDescription
Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)DRUG -
Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)DRUG -
Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories)DRUG -
Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)DRUG -
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Eligibility Criteria

Age Range18 Years to 40 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

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Frequently asked questions about Desipramine

What is Desipramine used for?

Desipramine is a small molecule developed for depression, a condition within the psychiatry therapeutic area. It is being studied by Novartis AG under ticker NVS. The clinical program to date has focused on depression as the target indication, with trials conducted in healthy adult male volunteers.

What does Desipramine target?

Desipramine targets SLC6A2, also known as the norepinephrine transporter. It acts as an inhibitor of this target. By inhibiting SLC6A2, desipramine affects norepinephrine reuptake, which is the mechanism underlying its activity in depression.

Who makes Desipramine?

Desipramine is developed by Novartis AG, which trades under the ticker NVS. The drug is also referenced as Desipramine Hydrochloride 100 mg Tablets and Desipramine Hydrochloride 50 mg Tablets, both associated with Cord Laboratories.

What phase is Desipramine in?

Desipramine is in Phase 1 clinical development. It is an investigational small molecule and has not been approved. Two Phase 1 trials have been completed, with no active trials currently listed. Total enrollment across the completed studies was 72 participants.

What clinical trials is Desipramine in?

Desipramine has been studied in two completed Phase 1 trials. NCT00913822 evaluated the relative bioavailability of desipramine hydrochloride tablets, and NCT00913237 evaluated the relative bioavailability of the 50 mg tablets. Both enrolled 36 healthy male volunteers and were active-controlled, randomized studies.