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Clinical trials
catalyst calendar across sponsors →Studies where HRTX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
25 interventional · 1 observational · 16 with posted results
Held by 10 tracked-famous managers (MILLENNIUM MANAGEMENT LLC, MARSHALL WACE, LLP, AQR CAPITAL MANAGEMENT LLC, RENAISSANCE TECHNOLOGIES LLC, Qube Research & Technologies Ltd, +5 more) · FINRA short interest 24.4 days to cover (settled 2026-07-31) · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Updated |
|---|---|---|---|---|---|---|---|
| Pediatric Postoperative Analgesia Herniorrhaphy StudyNCT03922048Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf)Randomized · Triple-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Withdrawn due to lack of enrollment. | Drug: HTX-011, Bupivacaine HCl, HTX-011, HTX-011, HTX-011 · Device: Luer Lock Applicator | Analgesia | 0 | Nov 2025 | 2026-05-12 |
| Safety Study of Repeat Doses of SUSTOL in AdultsNCT05434663Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL.Open-label · Prevention | Phase 4 | Unknown status | Drug: SUSTOL | Chemotherapy-Induced Nausea and Vomiting (CINV) | 300 | Oct 2025 | 2023-07-28 |
| A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.NCT05109312Incidence of treatment-emergent adverse events (TEAEs).Randomized · Double-masked · Treatment | Phase 4 | Unknown status | Drug: Bupivacaine Hydrochloride, Bupivacaine Hydrochloride, HTX-011, Ibuprofen, Acetaminophen · Device: Luer lock applicator | Analgesia | 90 | Jun 2024 | 2023-10-26 |
| HTX-011 in Spinal SurgeryNCT04911062Incidence of Serious Adverse EventsNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Bupivacaine HCI without epinephrine, HTX-011 · Device: Luer Lock Applicator | Post-Operative Pain, Lumbar Laminectomy | 32 | 2022-07-29actual | 2023-06-12 |
| A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.NCT06109415Incidence of treatment-emergent adverse events (TEAEs).Randomized · Double-masked · Treatment | Phase 4 | Completed | Drug: HTX-011, Bupivacaine Hydrochloride, Ibuprofen, Acetaminophen · Device: Luer lock applicator | Postoperative Pain, Total Shoulder Arthroplasty, Multimodal Analgesia | 30 | 2022-07-18actual | 2023-10-31 |
| A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZENCT06109428Incidence of treatment-emergent adverse events (TEAEs).Randomized · Double-masked · Treatment | Phase 4 | Completed | Drug: HTX-011, Bupivacaine Hydrochloride, Ibuprofen, Acetaminophen · Device: Luer lock applicator | Analgesia | 30 | 2022-03-29actual | 2023-10-31 |
| HTX-011 Administration Study in Planned Caesarean Section ProcedureNCT03955211Maximum plasma concentration (Cmax) of bupivacaine, meloxicam, dimethyl sulfoxide (DMSO) and HTX-011 polymerNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: HTX-011, HTX-011, Ibuprofen, Acetaminophen · Device: Luer Lock Applicator | Analgesia | 25 | 2021-12-03actual | 2022-03-14 |
| Study of Post-Herniorrhaphy Non-opioid MMA RegimensNCT03907176results2026-06-04Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 VisitNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: HTX-011, Ibuprofen, Acetaminophen · Device: Luer lock applicator | Analgesia | 209 | 2021-10-25actual | 2026-06-04 |
| Dose-Escalation Study of HTX-034 Following BunionectomyNCT04398329results2026-06-09Incidence of TEAEs in Phases 1b/2Randomized · Triple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: HTX-034 low dose, HTX-034 high dose, Bupivacaine HCl · Device: Luer lock applicator | Bunions, Postoperative Pain | 78 | 2021-07-15actual | 2026-06-09 |
| Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)NCT04470622results2022-08-30Proportion of Subjects Alive and Discharged From the Hospital.Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Study was terminated early by Heron, and was not terminated for safety reasons. | Drug: Aprepitant injectable emulsion, Saline Placebo | COVID-19 | 27 | 2021-04-09actual | 2026-03-02 |
| Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) RegimenNCT03974932results2023-08-31Mean Area Under the Curve (AUC) of the Visual Analogue Scale (VAS).Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: HTX-011, Ibuprofen, Acetaminophen, Celecoxib, +/- Bupivacaine HCl, HTX-011 · Device: Luer Lock Applicator | Analgesia | 116 | 2020-12-07actual | 2026-03-02 |
| Phase 2 Bunionectomy HTX-011 Administration StudyNCT03718039results2023-06-26Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity ScoresNon-randomized · Open-label · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: HTX-011, aprepitant · Device: Luer Lock applicator, Vial access device | Postoperative Pain | 78 | 2019-01-31actual | 2026-03-02 |
| Phase 2 Herniorrhaphy Study for Opioid EliminationNCT03695367results2021-07-02Percentage of Subjects Receiving no Opioid RescueNon-randomized · Open-label · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: HTX-011, Ibuprofen, Acetaminophen, Ketorolac · Device: Luer lock applicator, Vial access device | Postoperative Pain | 63 | 2018-11-20actual | 2026-03-02 |
| Bupivacaine HCl PK and Safety in Augmentation MammoplastyNCT03705065Maximum Observed Plasma Concentration (Cmax)Randomized · Open-label · Treatment | Phase 4 | Completed | Drug: Bupivacaine HCl | Analgesia | 30 | 2018-10-08actual | 2018-12-07 |
| Extended Delivery of Bupivacaine Study in HerniorrhaphyNCT04102267Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) through 72 hours (AUC0-72)Randomized · Open-label · Prevention | Phase 4 | Completed | Drug: Bupivacaine liposome injectable suspension, Bupivacaine HCl without epinephrine via continuous infusion | Analgesia | 32 | 2018-09-03actual | 2019-09-26 |
| Total Knee Arthroplasty Infiltration Study for Postoperative AnalgesiaNCT03015532results2021-10-27Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores at Rest (NRS-R) Through 48 Hours Postsurgery (AUC0-48).Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: HTX-011, Saline Placebo, Bupivicaine HCl, Ropivacaine | Postoperative Pain | 285 | 2018-04-20actual | 2026-03-02 |
| Phase 2B Upper Extremity Nerve Block StudyNCT03011333results2021-10-29Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 24 Hours Postsurgery (AUC0-24).Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: HTX-011, Bupivacaine HCl without epinephrine, Saline Placebo | Postoperative Pain | 243 | 2018-02-01actual | 2026-03-02 |
| Bunionectomy Study for Postoperative Analgesia (EPOCH 1)NCT03295721results2021-10-27Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Saline Placebo.Randomized · Triple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: HTX-011, Saline Placebo, Bupivacaine HCl · Device: Luer-lock applicator, Vial access device | Postoperative Pain | 412 | 2018-01-08actual | 2026-03-02 |
| Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)NCT03237481results2021-10-27Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Saline Placebo.Randomized · Triple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: HTX-011, Bupivacaine HCl, Saline placebo · Device: Luer-lock applicator, Vial access device | Postoperative Pain | 418 | 2017-12-22actual | 2026-03-02 |
| Pilot Herniorrhaphy Study for Postoperative AnalgesiaNCT02504580results2023-10-04Mean Summed Pain Intensity (SPI) ScoreRandomized · Double-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: HTX-011, Placebo, HTX-002, Bupivacaine HCI (Marcaine), HTX-011A, HTX-011B, HTX-009 | Postoperative Pain | 463 | Mar 2017actual | 2026-03-02 |
| Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty SurgeryNCT02689258results2023-10-04Summed Pain Intensity Scores Collected Over 24 HoursRandomized · Double-masked · OtherStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: HTX-011B, Placebo, HTX-011A, HTX-002, Bupivicaine HCl | Postoperative Pain | 277 | Mar 2017actual | 2026-03-02 |
| Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following BunionectomyNCT02762929results2023-10-04Mean Summed Pain Intensity (SPI) Score Over 24 HoursRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: HTX-011A, HTX-011B, HTX-002, Bupivacaine HCl, HTX-009 · Biological: Saline Placebo | Postoperative Pain, Bunions | 430 | Feb 2017actual | 2026-02-23 |
| HTX-011 for Post-bunionectomy AnalgesiaNCT02471898results2026-07-17SPI0-24Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: HTX-011, Placebo | Analgesia | 71 | Sep 2015actual | 2026-07-17 |
| A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HECNCT02106494results2016-12-28Delayed Phase Complete Response (CR) RateRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: APF530, Ondansetron, Ondansetron placebo, APF530 placebo, Fosaprepitant, Dexamethasone | Chemotherapy-induced Nausea and Vomiting | 942 | May 2015actual | 2026-03-02 |
| A Phase I Study of the Effects of APF530 Exposure, Granisetron and MoxifloxacinNCT01416259observationalQTc Prolongation | — | Completed | Drug: Withdraw treatment | Healthy | 56 | Oct 2011actual | 2026-02-12 |
| APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for CancerNCT00343460results2016-12-28Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1Randomized · Double-masked · Supportive care | Phase 3 | Completed | Drug: APF530, dexamethasone, Palonosetron Hydrochloride · Other: placebo | Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific | 1,428 | Sep 2008actual | 2026-03-02 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19