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Lonaprisan

Phase 2

Metastatic Breast Cancer | Small molecule | Oncology |Bayer AG|Trials Updated: Oct 10, 2014

Lonaprisan target and mechanism

Molecular targetPGR
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Lonaprisan clinical trials

Lonaprisan · 1 trial · 1 indication

Phase 2 1
NCT00555919ZK 230211 in Postmenopausal Woman With Metastatic Breast CancerMetastatic Breast Cancer
COMPLETED68 Analytics
PHASE2COMPLETED
ZK 230211 in Postmenopausal Woman With Metastatic Breast Cancer
Metastatic Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate efficacy (clinical benefit) of two doses of ZK PRA (25 mg and 100 mg) when administered once daily p.o.
month 3, month 6

Secondary Endpoints

To evaluate safety and tolerability
ongoing thoughout the trial
To evaluate the pharmacokinetics of ZK PRA
baseline, month1,2,6
To evaluate the effect of ZK PRA on quality of life (QoL)
baseline, month 1,2,3,4,5,6
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -

Interventions

NameTypeDescription
Lonaprisan (ZK 230211, BAY86-5044)DRUG25 mg daily oral treatment
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Postmenopausal women defined as: aged \>/= 50 years with amenorrhea for at least 12 months or aged \< 50 years with 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within postmenopausal range (\> 40 mIU/ml) or having undergone bilateral oophorec...

Countries:AustriaFinlandFranceGermanyItalyPolandSpainSwedenSwitzerlandUnited Kingdom
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Competitive Landscape -Breast Cancer 609 trials (matched to "Metastatic Breast Cancer")

Frequently asked questions about Lonaprisan

What is Lonaprisan used for?

Lonaprisan was studied for the treatment of metastatic breast cancer in postmenopausal women. It is an investigational small molecule developed by Bayer AG and has been evaluated in a Phase 2 clinical trial in this indication. It is not an approved therapy.

What does Lonaprisan target?

Lonaprisan targets the progesterone receptor, also known as PGR. It acts as a progesterone receptor antagonist, meaning it blocks the receptor's activity. This mechanism was the basis for its investigation in hormone-sensitive metastatic breast cancer.

Who is developing Lonaprisan?

Lonaprisan is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the clinical trial of Lonaprisan in metastatic breast cancer.

What phase is Lonaprisan in?

Lonaprisan is in Phase 2 development. It has completed one Phase 2 clinical trial in metastatic breast cancer. It is an investigational drug and is not FDA approved.

What clinical trials is Lonaprisan in?

Lonaprisan was evaluated in the Phase 2 trial NCT00555919, titled ZK 230211 in Postmenopausal Woman With Metastatic Breast Cancer. The trial enrolled 68 participants across ten European countries and is completed. No active trials are ongoing.

Is Lonaprisan the same as ZK 230211 or BAY86-5044?

Yes. Lonaprisan is also known as ZK 230211 and BAY86-5044. These are alternative names for the same investigational compound developed by Bayer AG.