Drugs / HTX-011
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Zynrelef | — | 2023-10-05 | europa.eu ↗ |
| Approved | EU (EMA) | Zynrelef | — | 2020-09-24 | europa.eu ↗ |
Trials 13 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 27 trials | ||||||
| Phase 2 | NCT03922048 | Jul 2023 → Nov 2025 | — | Heron Therapeutics | Withdrawn | No outcome recorded |
| Phase 2 | NCT03955211 | Jun 2019 → Dec 2021 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03718039 | Oct 2018 → Jan 2019 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03011333 | Jan 2017 → Feb 2018 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03015532 | Jan 2017 → Apr 2018 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT02504580 | Jul 2015 → Mar 2017 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT02471898 | Jun → Sep 2015 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT03974932 | Jun 2019 → Dec 2020 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT03237481 | Jul → Dec 2017 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT05188053 | Mar 2022 → Apr 2024 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT06109415 | Oct 2021 → Jul 2022 | — | Heron Therapeutics | Completed | No outcome recorded |
| Phase 4 | NCT05109312 | Oct 2021 → Jun 2024 | — | Heron Therapeutics | Unknown | No outcome recorded |
| Phase 4 | NCT06109428 | Oct 2021 → Mar 2022 | — | Heron Therapeutics | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT07280195 Comparator | Feb → Dec 2026 expected | — | Washington University School of Medicine | Enrolling by invitation | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HTX-011 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06109415 ↗ |
| Known as | HTX-011-19 | “HTX-011 is the initial formulation studied (HTX-011-19).” NCT02504580 ↗ |
| Known as | ZYNRELEF | “The purpose of this study is to determine if local intra-operative application of ZYNRELEF (topical medication) during shoulder replacement surgery improves pain control” NCT07280195 ↗3“Aim: HTX-011 (ZYNRELEF™) is an extended-release, dual-acting local anesthetic containing bupivacaine and meloxicam.” PMID 34284613 ↗ Jul 2021 “A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.” NCT06109415 ↗ |
| Route | Other | “HTX-011 (bupivacaine/meloxicam) by injection.” NCT02504580 ↗ |