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Enekinragene Inzadenovec

Phase 2

Osteoarthritis (OA) of the Knee | Monoclonal antibody | Musculoskeletal |Pacira BioSciences, Inc.|Last Updated: Aug 25, 2026

Target and mechanism

Target class-Vec/-gene (Gene Tx)
ModalityMonoclonal antibody

Also known as Enekinragene Inzadenovec (PCRX-201)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment135

FDA Designations

No designations recorded

Clinical trial landscape

Enekinragene Inzadenovec · 1 trial · 1 indication

Phase 2 1
NCT06884865A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the KneeOsteoarthritis (OA) of the Knee
RECRUITING135 Analytics
PHASE2RECRUITING
A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee
Osteoarthritis (OA) of the KneeUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence (number and percent) of treatment-emergent adverse events (TEAEs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52
Week 1 through Week 52.
Incidence (number and percent) of adverse events of special interest (AESIs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52
Week 1 through Week 52.
Incidence (number and percent) of serious adverse events (SAEs) for PCRX-201 Dose A and Dose B versus placebo from Week 1 through Week 52
Week 1 through Week 52.

Secondary Endpoints

Real-time quantitative polymerase chain reaction (qPCR) measurement profile in plasma of PCRX-201 Dose A and Dose B from postdose through Week 8
Days 1, 4, Weeks 2, 4, 8
Real-time qPCR measurement profile of skin swab samples from Baseline through Week 4.
Days 1, 4, Weeks 2, 4
Assessment of the levels of neutralizing antibodies (NAbs), high-sensitivity C-reactive protein (hs-CRP), and biomarkers of inflammation (eg, interleukin [IL]- 1, cytokines [tumor necrosis factor alpha (TNFα), IL-1β, IL-6, IL-10], and chemokines [IL-8])
Days 1, 4, Weeks 2, 3, 4,12, 16, 24, 38
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A Dose AEXPERIMENTALSingle Intra-Articular injection
Part A, PlaceboPLACEBO_COMPARATORSingle Intra-Articular injection
Part B Dose AEXPERIMENTALSingle Intra-Articular injection
Part B Dose BEXPERIMENTALSingle Intra-Articular injection
Part B PlaceboPLACEBO_COMPARATORPart B Placebo
Part A, Dose BEXPERIMENTALSingle Intra-Articular injection

Interventions

NameTypeDescription
Enekinragene Inzadenovec (PCRX-201)BIOLOGICALEnekinragene Inzadenovec (PCRX-201) injection
PlaceboBIOLOGICALPlacebo injection
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Eligibility Criteria

Age Range45 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Subjects must be willing and able to comply with the study procedures and visit schedule and able to follow verbal and written instructions. * Subjects must be male or female and 45 to 80 years old, inclusive, at Screening. * Subjects must exhibit symptoms associated with oste...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 25, 2026NCT06884865lastUpdatePostDate: changed
LOWAug 25, 2026NCT06884865lastUpdatePostDate: changed
LOWAug 7, 2026NCT06884865Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWAug 7, 2026NCT06884865Status: ACTIVE_NOT_RECRUITING → RECRUITING

Frequently asked questions about Enekinragene Inzadenovec

What is Enekinragene Inzadenovec used for?

Enekinragene Inzadenovec, also known as PCRX-201, is an investigational gene therapy being developed for the treatment of painful osteoarthritis (OA) of the knee. It is currently in Phase 2 clinical development and is not yet approved by the FDA.

What does Enekinragene Inzadenovec target?

Enekinragene Inzadenovec is a gene therapy, classified under the -vec/-gene target class. It is designed to deliver a gene to treat osteoarthritis of the knee, though the specific molecular target is not disclosed in the available information.

Who makes Enekinragene Inzadenovec?

Enekinragene Inzadenovec is developed by Pacira BioSciences, Inc., a company traded on the stock exchange under the ticker symbol PCRX. The drug is currently in Phase 2 clinical trials for osteoarthritis of the knee.

What phase is Enekinragene Inzadenovec in?

Enekinragene Inzadenovec is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being studied for safety and efficacy in patients with painful osteoarthritis of the knee.

What clinical trials is Enekinragene Inzadenovec in?

Enekinragene Inzadenovec is being studied in a Phase 2 clinical trial with the identifier NCT06884865. This randomized, double-blind, placebo-controlled trial is recruiting 135 participants in the United States to assess the safety and tolerability of the drug in subjects with painful osteoarthritis of the knee.

Is Enekinragene Inzadenovec the same as PCRX-201?

Yes, Enekinragene Inzadenovec is also known as PCRX-201. Both names refer to the same investigational gene therapy being developed by Pacira BioSciences for the treatment of osteoarthritis of the knee.