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Enekinragene Inzadenovec

Phase 2

Osteoarthritis (OA) of the Knee | Gene therapy | Musculoskeletal |Pacira BioSciences, Inc.|Trials Updated: Aug 25, 2026

Enekinragene Inzadenovec target and mechanism

Molecular targetIL1RA
Target class-Vec/-gene (Gene Tx)
ModalityGene therapy

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

Enekinragene Inzadenovec clinical trials

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

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 is an investigational gene therapy being developed for the treatment of painful osteoarthritis of the knee. It is designed to be given to patients with knee osteoarthritis, a musculoskeletal condition. The therapy is currently in Phase 2 clinical development and has not been approved for any use.

How does Enekinragene Inzadenovec work?

Enekinragene Inzadenovec targets IL1RA, the gene for the interleukin-1 receptor antagonist. By delivering this gene, the therapy aims to increase production of the IL1RA protein, which blocks interleukin-1 signaling. This mechanism is intended to reduce inflammation and pain associated with osteoarthritis of the knee. It is a gene therapy modality.

Who is developing Enekinragene Inzadenovec?

Enekinragene Inzadenovec is being developed by Pacira BioSciences, Inc., which trades on the Nasdaq under the ticker PCRX. Pacira is the sponsor of the clinical program for this gene therapy candidate in knee osteoarthritis.

What phase is Enekinragene Inzadenovec in?

Enekinragene Inzadenovec is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA or any regulatory agency. The ongoing Phase 2 trial is evaluating the therapy in patients with painful osteoarthritis of the knee.

What clinical trials is Enekinragene Inzadenovec in?

Enekinragene Inzadenovec is being studied in one active clinical trial, NCT06884865, titled A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee. This Phase 2 trial is currently recruiting and plans to enroll 135 participants in the United States.

Is Enekinragene Inzadenovec the same as PCRX-201?

Yes, Enekinragene Inzadenovec is also known as PCRX-201. PCRX-201 is the development code used by Pacira BioSciences for this gene therapy candidate. Both names refer to the same investigational product being studied in knee osteoarthritis.