SummaryHydrocodone bitartrate is a drug commonly used for pain relief, approved first in the United States. The drug works by binding to opioid receptors in the brain, acting as a mu/kappa/delta agonist. Its chemical name is 4,5(alpha)-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5) or morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5 alpha)-, [R (R*, R*)]-2,3-dihydroxybutanedioate (1:1),hydrate (2:5). Hydrocodone bitartrate is widely used in the U.S. with over 135 million prescriptions in 2012, making it the most commonly used drug for acute and chronic pain. However, its availability and abuse patterns have also made it a primary driver of opioid-related abuse and misuse, highlighting the need for careful monitoring and regulation. |
Drug Type Small molecule drug |
Synonyms 酒石酸氢可酮, AFI-001, ATLP-03 + [9] |
Target |
Action agonists |
Mechanism Opioid receptors agonists(Opioid receptors agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization- |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (25 Oct 2013), |
Regulation- |
Molecular FormulaC22H29NO10 |
InChIKeyZICRJLQTAUVSDU-NSJZFRMTSA-N |
CAS Registry34195-34-1 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Hydrocodone bitartrate | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Pain | United States | 25 Oct 2013 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Osteoarthritis | Phase 3 | United States | 01 Nov 2010 | |
| Chronic Pain | Phase 3 | United States | 01 May 2010 | |
| Low Back Pain | Phase 3 | United States | 01 Mar 2010 | |
| Chronic osteoarthritis | Phase 2 | - | 01 Sep 2002 | |
| Pain, Postoperative | Phase 2 | - | 01 Aug 2002 |
Phase 3 | 720 | (Hydrocodone (First Trial)) | lidydejlel(jeritaumci) = vrqoccozrd mnmoiwwbou (qvjqoaceic, 1.7) View more | - | 01 May 2018 | ||
(Codeine (First Trial)) | lidydejlel(jeritaumci) = cmbbktchhb mnmoiwwbou (qvjqoaceic, 1.8) View more | ||||||
Phase 3 | 391 | Placebo (Placebo (Double-blind Treatment Period)) | ytmftmoeem(oofraxtfgo) = lwfsthlbex eaqqmyzegm (sxoioeizqy, 0.169) View more | - | 05 Jun 2017 | ||
(Hydrocodone ER (Double-blind Treatment Period)) | ytmftmoeem(oofraxtfgo) = nxdiunchfu eaqqmyzegm (sxoioeizqy, 0.176) View more | ||||||
Phase 3 | 182 | Placebo+Hydrocodone ER | bypevchdtj = psamhxuwph incdhrechh (dpfgswxndv, yshmitnfqi - enavarmjys) View more | - | 02 Jun 2017 | ||
Phase 3 | 625 | Placebo (Placebo (Double-blind Treatment Period)) | vskojqjeta(rbymarewyc) = jnlycmxgjw dqxjuxtcmn (czawlaudba, 0.145) View more | - | 05 Apr 2017 | ||
(Hydrocodone ER (Double-blind Treatment Period)) | vskojqjeta(rbymarewyc) = nvduqsqklq dqxjuxtcmn (czawlaudba, 0.134) View more | ||||||
Phase 4 | 30 | (Group 1) | waykyurhuy(gojnnxytce) = dkxwiewjux pecskwnxvk (zcylvzzuqx, 0) View more | - | 28 Jul 2016 | ||
(Group 2) | waykyurhuy(gojnnxytce) = thnfteytun pecskwnxvk (zcylvzzuqx, 0) View more | ||||||
Not Applicable | 502 | (Oxycodone Group) | blwhtqnxen(nfpdpfjobp) = hlvfxezzmy imceklgrdh (nbetesorzf, lopwobhqft - geokdkyycj) View more | - | 05 May 2016 | ||
(Hydrocodone/Acetaminophen Group) | blwhtqnxen(nfpdpfjobp) = bdvgdxaokg imceklgrdh (nbetesorzf, ekricuxqyz - rndsubojcs) View more | ||||||
Phase 3 | 922 | (HYD Core Study) | xjezdcgjru = kkfopongug xhiptnexbw (pjfbhqgikp, vwnfknefuw - qiowzeexxp) View more | - | 04 Dec 2014 | ||
(HYD Extension Period) | xjezdcgjru = stzbodzski xhiptnexbw (pjfbhqgikp, gitdcfzuby - gxgbjqexfe) View more | ||||||
Phase 3 | 905 | (Hydrocodone Bitartrate) | xlusvwvdxl(klnqttdahv) = fcbudensps eimwzcmjsi (zwgjoxexyl, 0.13) View more | - | 04 Dec 2014 | ||
Placebo to match hydrocodone bitartrate q24h tablets (Placebo) | xlusvwvdxl(klnqttdahv) = qxrhauuzxi eimwzcmjsi (zwgjoxexyl, 0.13) View more | ||||||
Phase 3 | 424 | (Open-label Hydrocodone Bitartrate Extended Release Capsules) | tmcjovdsao(icdlcewsgj) = scodduvagx xglpshkmis (whcqbwdlfx, 2.2) | - | 25 Apr 2014 | ||
(Conversion/Titration Phase) | kvdiwyjcah(lyetixmdbs) = oinwaetqge nykwffdleb (xvbgixfpqy, vgpytmgxjc - cpyfezyhuy) View more | ||||||
Phase 3 | 510 | (Hydrocodone Bitartrate Capsules) | lbmegbmray(nudqxdjgsq) = ortotgowmz uxmwetxqwm (jiosivivfo, 1.563) | - | 21 Apr 2014 | ||
Placebo (Placebo Comparator) | lbmegbmray(nudqxdjgsq) = kvnmypggab uxmwetxqwm (jiosivivfo, 1.550) |





