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FP-101

Phase 2

Vasomotor Symptoms | Small molecule | Endocrine |Icon Plc|Last Updated: Oct 26, 2023

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment105

FDA Designations

No designations recorded

Clinical trial landscape

FP-101 · 1 trial · 2 indications

Phase 2 1
NCT05312567FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor SymptomsVasomotor Symptoms
COMPLETED105 Analytics
PHASE2COMPLETED
FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms
Vasomotor Symptoms
NCT05312567105
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Study Endpoints

Primary Endpoints

Change in the frequency (average daily number) of moderate-to-severe hot flashes.
Recorded every 12 hrs over a 1-week treatment period.

Subjects use a digital platform to record hot flash frequency in a daily eDiary.

Secondary Endpoints

Change in the severity (average daily rating) of moderate-to-severe hot flashes.
Recorded every 12 hrs over a 1-week treatment period.
Change in nighttime awakenings (average daily number) with or without night sweats.
Recorded every morning over a 1-week treatment period.
Evaluate the clinical meaningfulness of VMS changes after 1-week of treatment.
After 1 week of treatment at the end-of-study visit.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active Treatment (FP-101)EXPERIMENTALWhite to off-white extended-release, round tablets containing FP-101.
Matching placeboPLACEBO_COMPARATORWhite to off-white round tablets without the active ingredient but otherwise matching in size and appearance.

Interventions

NameTypeDescription
FP-101DRUGdaily oral tablet administration (b.i.d.)
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Eligibility Criteria

Age Range46 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Peri- and Post-Menopausal female subjects (\>45 yrs) experiencing a min of 7-8 moderate to severe hot flashes per day * Able/willing to provide informed consent. * Able/willing to complete all study procedures and visits. * Able/willing to not use any over-the-counter (OTC) co...

Countries:United States
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Frequently asked questions about FP-101

What is FP-101 used for?

FP-101 is an investigational small molecule being developed for the treatment of vasomotor symptoms, which are commonly associated with menopause. It is currently in Phase 2 clinical development and has been studied in a completed clinical trial for menopausal vasomotor symptoms.

What does FP-101 target?

FP-101 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for its effects on vasomotor symptoms, which include hot flashes and night sweats, though the exact mechanism of action is not publicly detailed.

Who is developing FP-101?

FP-101 is being developed by Icon Plc, a company publicly traded under the ticker symbol ICLR. The drug is currently in Phase 2 clinical development for the treatment of vasomotor symptoms.

What phase is FP-101 in?

FP-101 is in Phase 2 clinical development. It has completed one Phase 2 trial, and there are no active trials currently listed for this drug. It remains investigational and has not been approved by regulatory authorities.

What clinical trials is FP-101 in?

FP-101 has been studied in one completed clinical trial, identified as NCT05312567, titled 'FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms.' This Phase 2 trial enrolled 105 female participants in the United States and was placebo-controlled, double-blind, and randomized.

Is FP-101 the same as any other drug?

FP-101 is not known to have any alternative names. It is a distinct investigational drug being developed by Icon Plc for vasomotor symptoms, and no other names or aliases have been associated with it in clinical trial records.