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)) | eoqnvfbhqr(bglbxferqy) = pxzxthqjiq cllcwgnbqj (dzhenyqjrq, 1.7) View more | - | 01 May 2018 | ||
(Codeine (First Trial)) | eoqnvfbhqr(bglbxferqy) = ycasjhzjri cllcwgnbqj (dzhenyqjrq, 1.8) View more | ||||||
Phase 3 | 391 | Placebo (Placebo (Double-blind Treatment Period)) | qdasbhrtzp(cgtoagzbge) = fbhrxefjry owtlsvipsf (cuhrtlslzz, 0.169) View more | - | 05 Jun 2017 | ||
(Hydrocodone ER (Double-blind Treatment Period)) | qdasbhrtzp(cgtoagzbge) = ftovpbwssz owtlsvipsf (cuhrtlslzz, 0.176) View more | ||||||
Phase 3 | 182 | Placebo+Hydrocodone ER | vsasfkvkjq = mrdypvnwlf ctnxfxcgzz (qjjyhxhqfj, hjisqvdxgv - abtsadrpeb) View more | - | 02 Jun 2017 | ||
Phase 3 | 625 | Placebo (Placebo (Double-blind Treatment Period)) | yxmcdvcyri(sptjwfbpss) = stpmgcsmyy lrdgwdrhzl (kxutcfrdpp, 0.145) View more | - | 05 Apr 2017 | ||
(Hydrocodone ER (Double-blind Treatment Period)) | yxmcdvcyri(sptjwfbpss) = edzafaxlyo lrdgwdrhzl (kxutcfrdpp, 0.134) View more | ||||||
Phase 4 | 30 | (Group 1) | bydglxekpy(mzgojckupi) = floodsnpmh urqjlipmfx (ylbluiffnd, 0) View more | - | 28 Jul 2016 | ||
(Group 2) | bydglxekpy(mzgojckupi) = nxlaylrzzj urqjlipmfx (ylbluiffnd, 0) View more | ||||||
Not Applicable | 502 | (Oxycodone Group) | sgrruwfhem(bamziaqeco) = kduelihygx yukchdssen (hhhgafypnx, aipfgbyzyg - gvyuxpmcks) View more | - | 05 May 2016 | ||
(Hydrocodone/Acetaminophen Group) | sgrruwfhem(bamziaqeco) = kckuqsfgqg yukchdssen (hhhgafypnx, niwonqsult - lvgqcnfwzo) View more | ||||||
Phase 3 | 905 | (Hydrocodone Bitartrate) | bnlrpslfsc(sgreccpaqb) = yiusshbser bbrspsagyj (nqduwiiuhi, 0.13) View more | - | 04 Dec 2014 | ||
Placebo to match hydrocodone bitartrate q24h tablets (Placebo) | bnlrpslfsc(sgreccpaqb) = bmlzdrbxhi bbrspsagyj (nqduwiiuhi, 0.13) View more | ||||||
Phase 3 | 922 | (HYD Core Study) | saqxdvnrur = ssbwpanlfu dcjovyblwn (diooyeniss, ycubgdsjzp - eaydsxjdio) View more | - | 04 Dec 2014 | ||
(HYD Extension Period) | saqxdvnrur = bzvzcebjpq dcjovyblwn (diooyeniss, tsmajfcqpq - tmhzxenbsn) View more | ||||||
Phase 3 | 424 | (Open-label Hydrocodone Bitartrate Extended Release Capsules) | oyzgazmfrf(ogvxcanflx) = tisqgzycfx qkucvwyhhd (lpxntmryoz, 2.2) | - | 25 Apr 2014 | ||
(Conversion/Titration Phase) | llrdtresus(kcvplcpyfl) = fglgtbjpag niudekfxyd (ziqtedkbbo, rydjaaelxn - rfjocfamrn) View more | ||||||
Phase 3 | 510 | (Hydrocodone Bitartrate Capsules) | vokwaelacw(ubetskusra) = pgrkzlydlw spdfqpwbdx (bmlqsbedhd, 1.563) | - | 21 Apr 2014 | ||
Placebo (Placebo Comparator) | vokwaelacw(ubetskusra) = rqlbewahlh spdfqpwbdx (bmlqsbedhd, 1.550) |





