HERON THERAPEUTICS, INC. /DE/ (HRTX)
Heron Therapeutics, Inc. is a biotechnology firm dedicated to creating innovative therapies for critical patient requirements. The company leverages its proprietary Biochronomer drug delivery platform, an advanced system that enables the controlled release of various short-acting pharmacological agents. This technology ensures therapeutic concentrations are maintained for periods ranging from days to weeks following just a single administration. Among its commercialized products is SUSTOL (granisetron), an extended-release injectable designed to prevent both immediate and delayed nausea and vomiting triggered by moderately emetogenic chemotherapy, or specific anthracycline and cyclophosphamide combination therapies. Additionally, Heron markets CINVANTI, an intravenous formulation of aprepitant. CINVANTI, which acts as a substance P/neurokinin-1 receptor antagonist, is indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in patients undergoing highly or moderately emetogenic cancer chemotherapy. The company's development pipeline includes ZYNRELEF, an innovative dual-acting local anesthetic that combines bupivacaine, a local anesthetic, with a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam in a single fixed-dose formulation. Also in development is HTX-019, an experimental therapy aimed at preventing postoperative nausea and vomiting (PONV). Furthermore, HTX-034 is being advanced for postoperative pain management and is currently undergoing Phase Ib/II clinical trials, notably in patients recovering from bunionectomy procedures. Originally established in 1983 as A.P. Pharma, Inc., the company adopted its current name, Heron Therapeutics, Inc., in January 2014. Its corporate headquarters are situated in San Diego, California.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Heron Therapeutics, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 4Completed
Bupivacaine HCl PK and Safety in Augmentation Mammoplasty
Bupivacaine HCl
Postoperative Pain
NCT03705065Enrollment30StartSep 2018Primary CompletionOct 2018CompletionNov 2018 - Phase 4Completed
Extended Delivery of Bupivacaine Study in Herniorrhaphy
Bupivacaine liposome injectable suspension, Bupivacaine HCl without epinephrine via continuous infusion
Analgesia
NCT04102267Enrollment32StartJul 2018Primary CompletionSep 2018CompletionOct 2018 - Phase 4Active, not recruiting
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.
Bupivacaine Hydrochloride, Bupivacaine Hydrochloride
Analgesia
NCT05109312Enrollment90StartOct 2021Primary CompletionJun 2024est.CompletionJun 2024est. - Phase 4Active, not recruiting
Safety Study of Repeat Doses of SUSTOL in Adults
SUSTOL
Chemotherapy-Induced Nausea and Vomiting (CINV)
NCT05434663Enrollment300StartJul 2022Primary CompletionOct 2025est.CompletionOct 2025est. - Phase 4Completed
Cohort 1 (TSA) of: A Multi-surgery Assessment of ZYNRELEF (HTX-011)
HTX-011, Bupivacaine Hydrochloride
Postoperative Pain, Total Shoulder Arthroplasty +1
NCT06109415Enrollment30StartOct 2021Primary CompletionJul 2022CompletionJul 2022 - Phase 4Completed
Cohort 2 (Abdominoplasty) of: A Multi-surgery Assessment of ZYNRELEF (HTX-011)
MMA regimen, HTX-011
Postoperative Pain, Abdominoplasty Surgery +1
NCT06109428Enrollment37StartOct 2021Primary CompletionMar 2022CompletionApr 2022 - Phase 3Completed
APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
APF530, dexamethasone
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
NCT00343460Enrollment1,428StartJun 2006Primary CompletionSep 2008CompletionFeb 2009 - Phase 3Completed
A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC
APF530, Ondansetron
Chemotherapy-induced Nausea and Vomiting
NCT02106494Enrollment942StartMar 2014Primary CompletionMay 2015CompletionMay 2015 - Phase 3Completed
Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)
HTX-011, Bupivacaine HCl
Postoperative Pain
NCT03237481Enrollment418StartJul 2017Primary CompletionDec 2017CompletionJan 2018 - Phase 3Completed
Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
HTX-011, Saline Placebo
Postoperative Pain
NCT03295721Enrollment412StartOct 2017Primary CompletionJan 2018CompletionMar 2018 - Phase 3Completed
Study of Post-Herniorrhaphy Non-opioid MMA Regimens
HTX-011, Ibuprofen
Analgesia
NCT03907176Enrollment209StartApr 2019Primary CompletionOct 2021CompletionNov 2021 - Phase 3Completed
Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen
HTX-011, Ibuprofen
Analgesia
NCT03974932Enrollment116StartJun 2019Primary CompletionDec 2020CompletionJan 2021 - Phase 2Completed
HTX-011 for Post-bunionectomy Analgesia
HTX-011, Placebo
Analgesia
NCT02471898Enrollment71StartJun 2015Primary CompletionSep 2015CompletionSep 2015 - Phase 2Completed
Pilot Herniorrhaphy Study for Postoperative Analgesia
HTX-011, Placebo
Postoperative Pain
NCT02504580Enrollment463StartJul 2015Primary CompletionMar 2017CompletionApr 2017 - Phase 2Completed
Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty Surgery
HTX-011B, Placebo
Postoperative Pain
NCT02689258Enrollment277StartFeb 2016Primary CompletionMar 2017CompletionApr 2017 - Phase 2Completed
Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
HTX-011A, Saline Placebo
Postoperative Pain, Bunions
NCT02762929Enrollment430StartMay 2016Primary CompletionFeb 2017CompletionMar 2017 - Phase 2Completed
Phase 2B Upper Extremity Nerve Block Study
HTX-011, Bupivacaine HCl without epinephrine
Postoperative Pain
NCT03011333Enrollment243StartJan 2017Primary CompletionFeb 2018CompletionMar 2018 - Phase 2Completed
Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
HTX-011, Saline Placebo
Postoperative Pain
NCT03015532Enrollment285StartJan 2017Primary CompletionApr 2018CompletionMay 2018 - Phase 2Completed
Phase 2 Herniorrhaphy Study for Opioid Elimination
HTX-011, Ibuprofen
Postoperative Pain
NCT03695367Enrollment63StartOct 2018Primary CompletionNov 2018CompletionDec 2018 - Phase 2Completed
Phase 2 Bunionectomy HTX-011 Administration Study
HTX-011, aprepitant
Postoperative Pain
NCT03718039Enrollment78StartOct 2018Primary CompletionJan 2019CompletionMar 2019 - Phase 2Withdrawn
Pediatric Postoperative Analgesia Herniorrhaphy Study
HTX-011, Bupivacaine HCl
Analgesia
NCT03922048Enrollment0StartJul 2023est.Primary CompletionNov 2025est.CompletionDec 2025est. - Phase 2Completed
PK and Safety After C-Section
HTX-011, MMA regimen
Postoperative Pain
NCT03955211Enrollment25StartJun 2019Primary CompletionDec 2021CompletionDec 2021 - Phase 2Terminated
Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
Aprepitant injectable emulsion, Saline Placebo
COVID-19
NCT04470622Enrollment27StartJul 2020Primary CompletionApr 2021CompletionJun 2021 - Phase 2Completed
HTX-011 in Spinal Surgery
Bupivacaine HCI without epinephrine, HTX-011
Post-Operative Pain, Lumbar Laminectomy
NCT04911062Enrollment32StartApr 2022Primary CompletionJul 2022CompletionAug 2022 - Phase 1/2Completed
Dose-Escalation Study of HTX-034 Following Bunionectomy
HTX-034 low dose, HTX-034 high dose
Bunions, Postoperative Pain
NCT04398329Enrollment78StartMay 2020Primary CompletionJul 2021CompletionJul 2021
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 4 | Completed | Bupivacaine HCl | NCT03705065 |
| Phase 4 | Completed | Bupivacaine liposome injectable suspension, Bupivacaine HCl without epinephrine via continuous infusion | NCT04102267 |
| Phase 4 | Active, not recruiting | Bupivacaine Hydrochloride, Bupivacaine Hydrochloride | NCT05109312 |
| Phase 4 | Active, not recruiting | SUSTOL | NCT05434663 |
| Phase 4 | Completed | HTX-011, Bupivacaine Hydrochloride | NCT06109415 |
| Phase 4 | Completed | MMA regimen, HTX-011 | NCT06109428 |
| Phase 3 | Completed | APF530, dexamethasone | NCT00343460 |
| Phase 3 | Completed | APF530, Ondansetron | NCT02106494 |
| Phase 3 | Completed | HTX-011, Bupivacaine HCl | NCT03237481 |
| Phase 3 | Completed | HTX-011, Saline Placebo | NCT03295721 |
| Phase 3 | Completed | HTX-011, Ibuprofen | NCT03907176 |
| Phase 3 | Completed | HTX-011, Ibuprofen | NCT03974932 |
| Phase 2 | Completed | HTX-011, Placebo | NCT02471898 |
| Phase 2 | Completed | HTX-011, Placebo | NCT02504580 |
| Phase 2 | Completed | HTX-011B, Placebo | NCT02689258 |
| Phase 2 | Completed | HTX-011A, Saline Placebo | NCT02762929 |
| Phase 2 | Completed | HTX-011, Bupivacaine HCl without epinephrine | NCT03011333 |
| Phase 2 | Completed | HTX-011, Saline Placebo | NCT03015532 |
| Phase 2 | Completed | HTX-011, Ibuprofen | NCT03695367 |
| Phase 2 | Completed | HTX-011, aprepitant | NCT03718039 |
| Phase 2 | Withdrawn | HTX-011, Bupivacaine HCl | NCT03922048 |
| Phase 2 | Completed | HTX-011, MMA regimen | NCT03955211 |
| Phase 2 | Terminated | Aprepitant injectable emulsion, Saline Placebo | NCT04470622 |
| Phase 2 | Completed | Bupivacaine HCI without epinephrine, HTX-011 | NCT04911062 |
| Phase 1/2 | Completed | HTX-034 low dose, HTX-034 high dose | NCT04398329 |
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