Drugs / Enekinragene Inzadenovec
Enekinragene Inzadenovec
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04119687 | Mar 2020 → Nov 2023 overdue | osteoarthritis, knee | Pacira Pharmaceuticals, Inc | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06884865 | Feb 2025 → Jul 2032 expected | osteoarthritis, knee | Pacira Pharmaceuticals, Inc | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-08-06 | Pacira Pharmaceuticals, Inc | Results Pacira BioSciences Announces Publication of Positive Two-Year Phase 1 Data For PCRX-201 in Annals of the Rheumatic Diseases pacira.com ↗
Through two years of follow-up, exploratory outcome measures showed improvements in pain, stiffness, and function across all dose cohorts among patients who remained in the study. |
| 2025-10-28 | Pacira Pharmaceuticals, Inc | Results Pacira BioSciences Presents Updated Three-Year Data Demonstrating Sustained Efficacy and Safety of PCRX-201 Gene Therapy for Patients with Moderate-to-Severe Osteoarthritis of the Knee pacira.com ↗
Results show that a single intra-articular injection of PCRX-201 at each of the three doses tested was well tolerated and produced sustained improvements in pain, stiffness, and function through 156 weeks in patients with osteoarthritis of the knee. |
| 2025-06-11 | Pacira Pharmaceuticals, Inc | Results Pacira BioSciences Unveils Three-Year Clinical Data Following a Single Local Administration of Investigational Gene Therapy, PCRX-201, in Patients with Moderate-to-Severe Osteoarthritis of the Knee pacira.com ↗
Results show that a single intra-articular injection of PCRX-201 was well tolerated and produced sustained improvements in pain, stiffness, and function through 156 weeks in patients with moderate-to-severe osteoarthritis of the knee. |
| 2025-05-15 | Pacira Pharmaceuticals, Inc | Results Pacira BioSciences Presents New Data on the Effects of Clinical Immunogenicity on Locally Administered PCRX-201 in Patients with Moderate to Severe Osteoarthritis of the Knee pacira.com ↗
Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, today announced new preliminary data which suggests that clinical immunogenicity does not reduce sustained improvements in knee pain, stiffness and function provided by its gene therapy candidate, PCRX-201 (enekinragene inzadenovec), following local administration in patients with mild, moderate, as well as severe osteoarthritis of the knee. |
| 2025-05-06 | Pacira Pharmaceuticals, Inc | Results Pacira BioSciences to Present 3-Year Safety and Efficacy Data of PCRX-201 Following Single Intra-Articular Injection for Moderate-to-Severe Knee Osteoarthritis pacira.com ↗
Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced new data from its ongoing Phase 1 study of its gene therapy candidate PCRX-201 (enekinragene inzadenovec). |
| 2025-04-28 | Pacira Pharmaceuticals, Inc | Results Pacira BioSciences Announces Two-Year Efficacy Data Following a Single Local Administration of PCRX-201 in Patients with Mild to Severe Osteoarthritis of the Knee pacira.com ↗
Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced new data demonstrating its locally administered gene therapy candidate, PCRX-201 (enekinragene inzadenovec), provided sustained improvements in knee pain, stiffness, and function for up to two years following a single local administration in patients with mild, moderate, as well as severe osteoarthritis of the knee. |
| 2024-11-14 | Pacira Pharmaceuticals, Inc | Results Pacira Announces 104-Week Safety and Efficacy Data Following Local Administration of PCRX-201 for Moderate to Severe Osteoarthritis of the Knee pacira.com ↗
today announced new data demonstrating its gene therapy for osteoarthritis candidate, PCRX-201 (enekinragene inzadenovec), provided sustained improvements in knee pain, stiffness, and function to 104 weeks following local administration, with a well-tolerated safety profile. |
| 2024-03-13 | Pacira Pharmaceuticals, Inc | Regulatory Pacira BioSciences Announces PCRX-201 Granted Regenerative Medicine Advance Therapy (RMAT) Designation for the Treatment of Osteoarthritis of the Knee pacira.com ↗
We are honored to receive FDA’s first-ever RMAT designation for a gene therapy product candidate in osteoarthritis, |
All press releases naming this drug 15 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Enekinragene Inzadenovec | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06884865 ↗ |
| Known as | Enekinragen inzadenovec | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095333 ↗ |
| Known as | FX201 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04119687 ↗ |
| Known as | GQ-203 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095333 ↗ |
| Known as | humantakinogene hadenovec | “FX201, humantakinogene hadenovec, is a novel interleukin-1 receptor antagonist (IL-1Ra) gene therapy for IA administration” NCT04119687 ↗ |
| Known as | PCRX-201 | “Enekinragene Inzadenovec (PCRX-201) injection” NCT06884865 ↗ |
| Action | Inhibit | “interleukin-1 receptor antagonist (IL-1Ra)” NCT04119687 ↗ |
| Route | Other | “for IA administration” NCT04119687 ↗ |