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balicatib

Phase 2

Knee Osteoarthritis | Small molecule | Musculoskeletal |Novartis AG|Last Updated: Mar 28, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment223

FDA Designations

No designations recorded

Clinical trial landscape

balicatib · 1 trial · 1 indication

Phase 2 1
NCT00371670Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the KneeKnee Osteoarthritis
COMPLETED223 Analytics
PHASE2COMPLETED
Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee
Knee OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in knee cartilage volume in the target compartment after 6 months

Secondary Endpoints

Change from baseline in:
- Cartilage volume in the different regions of the knee after 6 and 12 months,
- Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months,
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
balicatib (AAE581)DRUG -
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Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * At least one knee with osteoarthritis with Kellgren-Lawrence grade 3 * Significant osteoarthritis pain in the knee * Presence of at least one of the risk factors: obesity (BMI \> 28), osteoarthritis at other sites, knee effusion, family history of total joint replacement Excl...

Countries:United StatesGermany
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Frequently asked questions about balicatib

What is balicatib used for?

Balicatib is an investigational small molecule being studied for the treatment of knee osteoarthritis, a degenerative joint disease. It is being developed by Novartis AG as a potential therapy for this condition, which affects the cartilage and surrounding tissues in the knee joint.

What does balicatib target?

Balicatib is a small molecule that targets cathepsin K, an enzyme involved in bone and cartilage remodeling. By inhibiting this enzyme, balicatib aims to slow the breakdown of cartilage in the knee joint, which is a key feature of osteoarthritis.

Who makes balicatib?

Balicatib is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Switzerland. Novartis is listed on the New York Stock Exchange under the ticker symbol NVS.

What phase is balicatib in?

Balicatib is in Phase 2 clinical development. It has completed a Phase 2 trial, but it is still considered investigational and has not been approved by regulatory authorities. The drug is not yet available for commercial use.

What clinical trials is balicatib in?

Balicatib has been studied in one completed Phase 2 clinical trial with the identifier NCT00371670. This trial, titled 'Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee,' enrolled 223 participants in the United States and Germany.

Is balicatib the same as AAE581?

Yes, balicatib is also known as AAE581. In clinical trial records, it is sometimes referred to by this alternative name, which is the compound designation used by the developer, Novartis.