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balicatib

Phase 2

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

balicatib target and mechanism

Molecular targetCTSK
Target classInhibitor
ModalitySmall molecule

Also known as balicatib (AAE581)

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

balicatib clinical trials

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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Competitive Landscape -Osteoarthritis 143 trials (matched to "Knee Osteoarthritis")

Frequently asked questions about balicatib

What is balicatib used for?

Balicatib was studied for the treatment of knee osteoarthritis in adults. It is an investigational small molecule that was evaluated in a Phase 2 clinical trial in patients with osteoarthritis of the knee. It is not an approved therapy.

What does balicatib target?

Balicatib targets cathepsin K, also known as CTSK. It is a small molecule inhibitor of this enzyme. Cathepsin K is a protease involved in the breakdown of collagen in bone and cartilage, which is relevant to joint degeneration in osteoarthritis.

Who is developing balicatib?

Balicatib was developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 2 clinical trial of balicatib in knee osteoarthritis.

What phase is balicatib in?

Balicatib reached Phase 2 clinical development. It has not been approved by the FDA and remains an investigational drug. The Phase 2 trial in knee osteoarthritis has been completed.

What clinical trials is balicatib in?

Balicatib was studied in one completed Phase 2 trial, NCT00371670, titled Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee. The trial enrolled 223 participants across the United States and Germany and was randomized and double blind.

Is balicatib the same as AAE581?

Yes, balicatib is also known as AAE581. Both names refer to the same investigational cathepsin K inhibitor developed by Novartis. The Phase 2 knee osteoarthritis trial used the designation balicatib (AAE581).