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Octreotide pamoate

Phase 2

Undisclosed | Small molecule | Other |Novartis AG|Trials Updated: Dec 3, 2015

Octreotide pamoate development status

Highest phase Phase 2 run by University of Southern California (NCT01469338)
Phase scored for NVSPhase 1
Registered trials 2 across 2 sponsors since Feb 2007

Octreotide pamoate target and mechanism

Molecular targetSSTR5, SSTR2, SSTR4, SSTR1, SSTR3
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Octreotide pamoate clinical trials

Octreotide pamoate · 1 trial · 1 indication

Phase 1 1
NCT00432068Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy VolunteersHealthy Cholecystectomized
COMPLETED48 Analytics
PHASE1COMPLETED
Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers
Healthy CholecystectomizedUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics of a single dose of an extended long-acting formulation of octreotide pamoate
30min, 1, 2, 3, 4, 6, 8, 10, 12 and 24hrs post dose; Thereafter every 5 days for the first 40 days and every 7 days until study completion, 5 to 10 mins apart.
Safety and tolerability assessed by physical exam, ecg, laboratory data and adverse event monitoring
48 hrs post study drug administration

Secondary Endpoints

To determine the relative bioavailability of a single dose of an extended long-acting formulation of octreotide pamoate
30min, 1, 2, 3, 4, 6, 8, 10, 12 and 24hrs post dose. Thereafter every 5 days for the first 40 days and every 7 days until study completion, 5 to 10 mins apart
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Octreotide pamoateEXPERIMENTAL -

Interventions

NameTypeDescription
Octreotide pamoateDRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion criteria: * Male or female from 18-60 years of age, cholecystectomized at least 4 months prior to the start of the study. * In a good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening * Body mass index with...

Countries:BelgiumFranceItaly
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Frequently asked questions about Octreotide pamoate

What is Octreotide pamoate?

Octreotide pamoate is an investigational long-acting formulation of octreotide, a small molecule somatostatin receptor agonist developed by Novartis AG. It is designed as an extended-release depot version of octreotide. The specific clinical indications for this pamoate formulation have not been disclosed. It remains in Phase 1 clinical development.

What does Octreotide pamoate target?

Octreotide pamoate targets somatostatin receptors SSTR1, SSTR2, SSTR3, SSTR4, and SSTR5, acting as an agonist at these receptors. Its pharmacologic activity is mediated through binding and activating these G protein-coupled receptors, with highest affinity typically associated with SSTR2 and SSTR5.

Who makes Octreotide pamoate?

Octreotide pamoate is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor responsible for the clinical development of this extended long-acting formulation.

What phase is Octreotide pamoate in?

Octreotide pamoate is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The only recorded trial is a completed Phase 1 study in healthy volunteers.

What clinical trials is Octreotide pamoate in?

Octreotide pamoate has been studied in one completed Phase 1 trial, NCT00432068, titled an open label study of a single dose of a new extended long acting formulation of octreotide pamoate in healthy volunteers. It enrolled 48 healthy cholecystectomized participants across Belgium, France, and Italy. No active trials are ongoing.

Is Octreotide pamoate the same as octreotide?

Octreotide pamoate is a distinct long-acting pamoate salt formulation of octreotide, not identical to immediate-release octreotide. It is being developed as an extended-release depot version. The active moiety is octreotide, but the pamoate salt alters its release profile.