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teverelix TFA

Phase 2

Prostatic Adenoma | Small molecule | Oncology |Medicus Pharma Ltd.|Trials Updated: Jul 23, 2024

teverelix TFA development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Dec 2018

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

teverelix TFA clinical trials

teverelix TFA · 1 trial · 1 indication

Phase 2 1
NCT04693507Teverelix Evaluated in Advanced Prostate CancerProstatic Adenoma
COMPLETED50 Analytics
PHASE2COMPLETED
Teverelix Evaluated in Advanced Prostate Cancer
Prostatic AdenomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Testosterone (T) Levels (Castrate) at Week 4
4 weeks

Proportion of participants achieving castration level with serum T \<0.5 ng/mL at Day 28.

Secondary Endpoints

Testosterone (T) Levels (0.2 ng/mL) at Week 4
4 weeks
Testosterone (T) Levels (Castrate) at Week 6
6 weeks
Testosterone (T) Levels (0.2 ng/mL) at Week 6
6 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Teverelix TFA 120 mg 6-weeklyEXPERIMENTALParticipants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24
Teverelix TFA 180 mg 6-weeklyEXPERIMENTALParticipants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24

Interventions

NameTypeDescription
teverelix TFA 120 mgDRUGTeverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24
teverelix TFA 180 mgDRUGTeverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24
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Eligibility Criteria

Age Range18 Years to 80 Years
SexMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Is male, aged ≤80 years (≥18 years) at the beginning of the treatment period (Day 0) * Has histologically proven advanced adenocarcinoma of the prostate (metastatic or non metastatic hormone-sensitive non curative), suitable for ADT * Is treatment naïve for any of the followin...

Countries:Lithuania
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Frequently asked questions about teverelix TFA

What is teverelix TFA used for?

Teverelix TFA is being studied for prostatic adenoma, a non-cancerous enlargement of the prostate. It is also known as teverelix TFA 120 mg. The drug is an investigational small molecule in Phase 2 development, and it has been evaluated in a completed Phase 2 trial in adult men with this condition.

Who is developing teverelix TFA?

Teverelix TFA is being developed by Medicus Pharma Ltd., which trades under the ticker MDCX. The company is responsible for the clinical program evaluating the drug in prostatic adenoma.

What phase is teverelix TFA in?

Teverelix TFA is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is teverelix TFA in?

Teverelix TFA has been studied in one completed Phase 2 trial, NCT04693507, titled Teverelix Evaluated in Advanced Prostate Cancer. The trial enrolled 50 male participants aged 18 years and older in Lithuania. It was a controlled study without randomization or double-blinding.