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YM087

Phase 3

Hyponatremia | Small molecule | Nephrology |Cumberland Pharmaceuticals Inc.|Last Updated: May 2, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment167

FDA Designations

No designations recorded

Clinical trial landscape

YM087 · 2 trials · 1 indication

Phase 3 2
NCT00380575Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic HyponatremiaHyponatremia
COMPLETED84 Analytics
NCT00492037Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic HyponatremiaHyponatremia
COMPLETED83 Analytics
PHASE3COMPLETED
Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia
HyponatremiaUnlock trial analytics
PHASE3COMPLETED
Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia
HyponatremiaUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements).
Change in serum sodium from Baseline Safety of each dosing regimen
Beginning through end of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
YM087DRUG -
YM087 oralDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites47

Inclusion Criteria: * Serum sodium levels 115 to \< 130mEq/L * Euvolemic or Hypervolemic hyponatremia Exclusion Criteria: * Clinical evidence of volume depletion or dehydration * Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency * Uncontrolled brady-or tachyarrhythmias re...

Countries:United StatesCanadaIsraelSouth AfricaBelgiumFinlandFranceGermanyItalyNetherlandsPolandSpainUnited Kingdom
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Frequently asked questions about YM087

What is YM087 used for?

YM087 is an investigational small molecule being developed for the treatment of hyponatremia, a condition of abnormally low sodium levels in the blood. It is studied in patients with euvolemic or hypervolemic hyponatremia, meaning those with normal or excess fluid volume. The drug is in Phase 3 clinical development.

Who makes YM087?

YM087 is being developed by Cumberland Pharmaceuticals Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol CPIX. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with hyponatremia.

What phase is YM087 in?

YM087 is in Phase 3 clinical development for hyponatremia. Two Phase 3 trials have been completed, one evaluating an intravenous formulation and another evaluating an oral formulation. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is YM087 in?

YM087 has completed two Phase 3 clinical trials. NCT00380575 studied intravenous YM087 in 84 patients with euvolemic or hypervolemic hyponatremia in the United States, Canada, Israel, and South Africa. NCT00492037 studied oral YM087 in 83 patients across several European countries.

How does YM087 work?

YM087 is a small molecule that targets the vasopressin receptor system to correct sodium imbalances in patients with hyponatremia. By modulating this pathway, it aims to increase serum sodium levels in individuals with euvolemic or hypervolemic hyponatremia.