15 completed, 1 not yet recruiting, 1 unknown, 1 withdrawn. 9 Phase 2, 5 Phase 4, 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 8, Withdrawn 1 |
| Phase 4 | 5 | Completed 3, Not yet recruiting 1, Unknown 1 |
| Phase 3 | 4 | Completed 4 |
Follow HTX-011: new trials by email Literature Review of HTX-011 trials Research Report on HTX-011
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Zynrelef Versus Adductor Canal Block ZYNRELEF 400Mg-12Mg Extended-Release Solution, Ultrasound-Guided Adductor Canal Block, Ropivacaine 0.5% Injectable Solution - Knee Osteoarthritis, Arthritis Knee | Phase 4 | Not yet recruiting | University of Miami | 120 | 2027-01-01 | 2026-06-12 |
| Pediatric Postoperative Analgesia Herniorrhaphy Study HTX-011, Bupivacaine HCl, Luer Lock Applicator - Analgesia | Phase 2 | Withdrawn | Heron Therapeutics | 2023-07-01 | 2026-05-12 | |
| HTX-011 in Spinal Surgery Bupivacaine HCI without epinephrine, HTX-011, Luer Lock Applicator - Post-Operative Pain, Lumbar Laminectomy | Phase 2 | Completed | Heron Therapeutics | 32 | 2022-04-07 | 2023-06-12 |
| Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty HTX-011, ropivacaine , epinephrine , ketorolac diluted in sodium chloride - Total Knee Arthroplasty | Phase 4 | Completed | Mayo Clinic | 209 | 2022-03-11 | 2025-04-27 |
| Cohort 1 (TSA) of: A Multi-surgery Assessment of ZYNRELEF (HTX-011) HTX-011, Bupivacaine Hydrochloride, MMA regimen - Postoperative Pain, Total Shoulder Arthroplasty | Phase 4 | Completed | Heron Therapeutics | 30 | 2021-10-20 | 2026-10-27 |
| A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401. Bupivacaine Hydrochloride, HTX-011, Luer lock applicator - Analgesia | Phase 4 | Unknown | Heron Therapeutics | 90 | 2021-10-12 | 2023-10-26 |
| Cohort 2 (Abdominoplasty) of: A Multi-surgery Assessment of ZYNRELEF (HTX-011) MMA regimen, ZYNRELEF kit components for administration, HTX-011 - Postoperative Pain, Abdominoplasty Surgery | Phase 4 | Completed | Heron Therapeutics | 37 | 2021-10-12 | 2026-10-28 |
| PK and Safety After C-Section HTX-011, ZYNRELEF kit components for administration, MMA regimen - Postoperative Pain | Phase 2 | Completed | Heron Therapeutics | 25 | 2019-06-24 | 2026-10-27 |
| Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen HTX-011, Ibuprofen, Acetaminophen - Analgesia | Phase 3 | Completed | Heron Therapeutics | 116 | 2019-06-05 | 2026-03-02 |
| Study of Post-Herniorrhaphy Non-opioid MMA Regimens HTX-011, Luer lock applicator, Ibuprofen - Analgesia | Phase 3 | Completed | Heron Therapeutics | 209 | 2019-04-04 | 2026-06-04 |
| Phase 2 Bunionectomy HTX-011 Administration Study HTX-011, Luer Lock applicator, Vial access device - Postoperative Pain | Phase 2 | Completed | Heron Therapeutics | 78 | 2018-10-24 | 2026-03-02 |
| Phase 2 Herniorrhaphy Study for Opioid Elimination HTX-011, Luer lock applicator, Vial access device - Postoperative Pain | Phase 2 | Completed | Heron Therapeutics | 63 | 2018-10-01 | 2026-03-02 |
| Bunionectomy Study for Postoperative Analgesia (EPOCH 1) HTX-011, Saline Placebo, Bupivacaine HCl - Postoperative Pain | Phase 3 | Completed | Heron Therapeutics | 412 | 2017-10-24 | 2026-03-02 |
| Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2) HTX-011, Bupivacaine HCl, Saline placebo - Postoperative Pain | Phase 3 | Completed | Heron Therapeutics | 418 | 2017-07-31 | 2026-03-02 |
| Phase 2B Upper Extremity Nerve Block Study HTX-011, Bupivacaine HCl without epinephrine, Saline Placebo - Postoperative Pain | Phase 2 | Completed | Heron Therapeutics | 243 | 2017-01-14 | 2026-03-02 |
| Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia HTX-011, Saline Placebo, Bupivicaine HCl - Postoperative Pain | Phase 2 | Completed | Heron Therapeutics | 285 | 2017-01-13 | 2026-03-02 |
| Pilot Herniorrhaphy Study for Postoperative Analgesia HTX-011, Placebo, HTX-002 - Postoperative Pain | Phase 2 | Completed | Heron Therapeutics | 463 | 2015-07-01 | 2026-03-02 |
| HTX-011 for Post-bunionectomy Analgesia HTX-011, Placebo - Analgesia | Phase 2 | Completed | Heron Therapeutics | 71 | 2015-06-01 | 2026-07-17 |
Pain, Postoperative (15) · Agnosia (5) · Hernia, Inguinal (4) · Hernia (3) · Bunion (2) · Osteoarthritis, Knee (1)
Heron Therapeutics (16) · Mayo Clinic (1) · University of Miami (1)
United States (17) · Belgium (1)
Colin A. McNamara, MD,MBA (1) · Matthew P Abdel, MD (1) · Neil Singla, MD (1)