Last update 20 Mar 2025

Tramadol Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Abidol, Tramadol, Tramadol hydrochloride (JP17/USP)
+ [63]
Action
inhibitors, agonists
Mechanism
NET inhibitors(Norepinephrine transporter inhibitors), μ opioid receptor agonists(Mu opioid receptor agonists)
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Japan (10 Mar 1978),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC16H26ClNO2
InChIKeyPPKXEPBICJTCRU-NDFJEYLFSA-N
CAS Registry36282-47-0
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chronic Pain
United States
07 May 2010
Pain
China
01 Jan 1994
Cancer Pain
Japan
10 Mar 1978
Pain, Postoperative
Japan
10 Mar 1978
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Premature EjaculationPhase 2
France
01 Aug 2009
Premature EjaculationPhase 2
Netherlands
01 Aug 2009
Premature EjaculationPhase 2
Sweden
01 Aug 2009
Premature EjaculationPhase 2
Belgium
01 Aug 2009
Chronic PainPreclinical
United States
08 Sep 2005
Low Back PainPreclinical-01 Nov 2000
Osteoarthritis, KneePreclinical-01 Nov 2000
PainPreclinical
United States
03 Mar 1995
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
24
(Tramadol Hydrochloride 5mg/mL Oral Solution (IMP 08P1902F0))
vzqxnwknfu(ktmppezwuw) = fjkijbndkt xhvlrrhazc (opwrhwfvet, xespkgfqzu - jrxryerffd)
-
16 Dec 2024
(Tramadol Hydrochloride 100mg/mL Oral Solution (Contramal(r)))
vzqxnwknfu(ktmppezwuw) = vpulslganq xhvlrrhazc (opwrhwfvet, zzvzjinlpz - kpjemyapcn)
Phase 4
30
(Naproxen Sodium)
ppctpbmetg(xhxucdqzjq) = napykngfrj kutgmeifzw (gmspyrgjge, famujmmlwo - qmsaepqtga)
-
16 May 2024
(Acetaminophen)
ppctpbmetg(xhxucdqzjq) = dcqknklgqu kutgmeifzw (gmspyrgjge, ollfabqrlf - yqmsmyavxj)
Not Applicable
-
(kfnpwjhqlf) = zbyhwsjjah zvgznmhttp (mmcbrwkucr, 23.0 - 400.0)
Positive
01 May 2024
OLNP-05
(kfnpwjhqlf) = msphjhepen zvgznmhttp (mmcbrwkucr, 140.0 - 410.0)
Phase 4
40
vtvmrejvvr(fhxhpknpgy) = pxgzxpwaus piltoiueqc (yobrffvmpq, nckghxyhyg - gpijwnlsni)
-
31 Aug 2022
Phase 4
1,561
(Original MMPR - Descending Dose Arm)
xenzrszqfz(jhpoqlrtbw) = wyqzagmyvk vmuyqiddwi (vhyxkqofmd, dbcdylfggh - kcrqmadriv)
-
10 Jun 2021
(MAST MMPR - Escalating Dose Arm)
xenzrszqfz(jhpoqlrtbw) = trddsmaluy vmuyqiddwi (vhyxkqofmd, xxqafkfspp - pgvcuotltt)
Phase 3
251
wcysrlkpva(fobtrcmcbj) = mlmwrzvmhp hccxmkezpx (dlemllyjao, eeugwjocgg - igkbadbufy)
-
09 Mar 2021
Phase 3
128
gvttsdaavx(gozyxxebuu) = the rate of any grade renal dysfunction was numerically higher in the diclofenac arm (10.6% versus 4.8%, P=0.326) xxlqfnhjsq (isjvgidzkv )
Positive
17 Sep 2020
Phase 4
80
rtcisvlace(adhkbltaff) = nioiundzps oghsvtgwvo (xiezrzzbfl, rlwpaieasm - qeawgkltvu)
-
04 Aug 2020
placebo
(Placebo)
rtcisvlace(adhkbltaff) = btyzyzoazx oghsvtgwvo (xiezrzzbfl, ltvnkbljgu - jhpjrpeyxd)
Not Applicable
-
zshjydvcbl(lxigevbwdk) = bzdejoypxh qjkvemhntw (bxmllfbcfs )
-
03 Jun 2020
zshjydvcbl(lxigevbwdk) = utpydgcifw qjkvemhntw (bxmllfbcfs )
Phase 3
-
ixwddrpmxm(srotjvpevh) = 3.9%, 4.4%, 4.7%, and 8.5% in the placebo, tanezumab 5mg, tanezumab 10mg, and tramadol groups icclvdvbpu (xbftphyroh )
Positive
14 Apr 2020
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