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Mifepristone daily

Phase 2

Treatment-resistant PTSD | Small molecule | Psychiatry |Corcept Therapeutics Incorporated|Last Updated: Nov 14, 2024

Target and mechanism

Molecular targetPGR, NR3C1
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Mifepristone daily · 1 trial · 1 indication

Phase 2 1
NCT06689254REVERSE: Improving Treatment-resistant Post Traumatic Stress Disorder (PTSD) with Glucocorticoid Receptor (GR) AntagonismTreatment-resistant PTSD
RECRUITING60 Analytics
PHASE2RECRUITING
REVERSE: Improving Treatment-resistant Post Traumatic Stress Disorder (PTSD) with Glucocorticoid Receptor (GR) Antagonism
Treatment-resistant PTSDUnlock trial analytics

Study Endpoints

Primary Endpoints

Improvement of PTSD symptoms
4 weeks after the start of the intervention (T2)

Measured with the monthly version of the CAPS-5 (Clinician Administered PTSD scale) in patients with treatment-resistant PTSD. Minimum and maximum score range from 0-80, with higher scores indicating greater PTSD symptom severity.

Secondary Endpoints

PTSD symptom severity
From baseline till 12 weeks after the start of the intervention (T3)
Long-term PTSD symptom severity
12 weeks after the start of the intervention (T3)
Loss of diagnosis
4 weeks after the start of the intervention (T2)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MifepristoneEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Mifepristone 1200 mg dailyDRUGOral tablets
PlaceboDRUGOral tablet
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Mastery of Dutch language * Age of ≥ 18 years of age and able to give written IC * Participant agrees to be randomized * DSM-5 diagnosis of PTSD, confirmed with clinical interview (CAPS-5) * Treatment-resistant PTSD * CAPS-5 score ≥ 30 * Nonresponse to two evidence-based ...

Countries:Netherlands
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Frequently asked questions about Mifepristone daily

What is Mifepristone daily used for?

Mifepristone daily, also known as Mifepristone 1200 mg daily, is an investigational small molecule being studied for the treatment of treatment-resistant PTSD. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does Mifepristone daily target?

Mifepristone daily targets the glucocorticoid receptor (GR). It is a GR antagonist, meaning it blocks the receptor's activity. This mechanism is being investigated in the context of treatment-resistant PTSD, as GR antagonism may help modulate stress-related pathways.

Who makes Mifepristone daily?

Mifepristone daily is being developed by Corcept Therapeutics Incorporated, a biopharmaceutical company. The company's stock ticker is CORT. The drug is currently in Phase 2 clinical trials for treatment-resistant PTSD.

What phase is Mifepristone daily in?

Mifepristone daily is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is actively recruiting participants.

What clinical trials is Mifepristone daily in?

Mifepristone daily is being evaluated in one active Phase 2 clinical trial, NCT06689254, titled "REVERSE: Improving Treatment-resistant Post Traumatic Stress Disorder (PTSD) with Glucocorticoid Receptor (GR) Antagonism." This randomized, double-blind, placebo-controlled trial is recruiting 60 participants in the Netherlands.

Is Mifepristone daily the same as Mifepristone 1200 mg daily?

Yes, Mifepristone daily is also known as Mifepristone 1200 mg daily. The two names refer to the same investigational drug being developed by Corcept Therapeutics for treatment-resistant PTSD.