Drugs / Hydrocodone bitartrate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | HYCODAN | — | 1943-03-23 | fda.gov ↗ |
Trials 6
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06585163 | Sep → Dec 2024 overdue | — | Quivive Pharma, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05572190 | Sep 2022 → Mar 2024 | — | Elysium Therapeutics, Inc. | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02542098 | Jan 2017 → Jul 2019 | — | Purdue Pharma LP | Withdrawn | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT01722864 | Nov 2012 → Feb 2013 | chronic pain syndrome, osteoarthritis, hip, osteoarthritis, knee | Mallinckrodt | Completed | No outcome recorded |
| Phase 3 | NCT01115569 | May 2010 → Jan 2012 | chronic pain syndrome | Zogenix, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00390260 | Feb 2002 → Feb 2003 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 2 | NCT07807644 Comparator | Sep 2026 → Sep 2027 expected | — | Grünenthal GmbH | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05034952 Comparator | Aug → Dec 2021 | — | Vertex Pharmaceuticals Incorporated | Completed | Met primary |
| Phase 2 | NCT04977336 Comparator | Jul 2021 → Feb 2022 | — | Vertex Pharmaceuticals Incorporated | Completed | Met primary |
| Phase 2 | NCT03206749 Comparator | Jun → Dec 2017 | — | Vertex Pharmaceuticals Incorporated | Completed | Met primary |
| Phase 2 | NCT01759446 Comparator | Feb → Apr 2013 | substance-related disorder | Acura Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT07296770 Background | Oct 2026 → Dec 2028 expected | chronic pain syndrome | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05558410 Comparator | Oct 2022 → Aug 2023 | — | Vertex Pharmaceuticals Incorporated | Completed | Met primary |
| Phase 3 | NCT05553366 Comparator | Oct 2022 → Dec 2023 | — | Vertex Pharmaceuticals Incorporated | Completed | Met primary |
| Phase 3 | NCT01081912 Comparator | Mar 2010 → Oct 2011 | — | Zogenix, Inc. | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Hydrocodone Bitartrate | “MNK-155, a biphasic (immediate-release/extended-release) hydrocodone bitartrate/N-acetyl-p-aminophenol (acetaminophen) (IR/ER HB/APAP) 7.5/325-mg fixed-dose combination analgesic agent” PMID 25913923 ↗ Apr 201513“VYCAVERT (hydrocodone bitartrate and acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen)” NCT01759446 ↗ “hydrocodone bitartrate-acetaminophen (5 mg of hydrocodone bitartrate and 325 mg of acetaminophen every 6 hours)” PMID 37530822 ↗ Aug 2023 “5 mg hydrocodone bitartrate (HCBT) single oral dose (fasted)” NCT05572190 ↗ “Hydrocodone bitartrate/acetaminophen (HB/APAP)” NCT05553366 ↗ “Hydrocodone Bitartrate/Acetaminophen (HB/APAP)” NCT03206749 ↗ “Hydrocodone bitartrate/acetaminophen (HB/APAP)” NCT05558410 ↗ “Hydrocodone Bitartrate and Acetaminophen” NCT07296770 ↗ “Hydrocodone Bitartrate (HYD) tablets” NCT02542098 ↗ |
| Known as | HCBT | “5 mg hydrocodone bitartrate (HCBT) single oral dose (fasted)” NCT05572190 ↗ |
| Known as | HYD | “Hydrocodone Bitartrate (HYD) tablets” NCT02542098 ↗ |
| Route | Oral | “by mouth (PO)” NCT01115569 ↗ |