Last update 07 Sep 2026

Bupivacaine/Meloxicam

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Meloxicam/bupivacaine, ZYNRELEF, HTX-002/HTX-009
+ [5]
Action
inhibitors, modulators
Mechanism
COX-1 inhibitors(Cyclooxygenase-1 inhibitors), COX-2 inhibitors(Cyclooxygenase-2 inhibitors), SCNA modulators(Sodium voltage-gated channel alpha subunits modulators)
Active Indication
Inactive Indication
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (24 Sep 2020),
RegulationFast Track (United States)
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Structure/Sequence

Molecular FormulaC18H28N2O
InChIKeyLEBVLXFERQHONN-UHFFFAOYSA-N
CAS Registry38396-39-3
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
D12270--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pain, Postoperative
European Union
24 Sep 2020
Pain, Postoperative
Iceland
24 Sep 2020
Pain, Postoperative
Liechtenstein
24 Sep 2020
Pain, Postoperative
Norway
24 Sep 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AnalgesiaPhase 3
United States
04 Apr 2019
BunionPhase 2
United States
01 May 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
209
Luer lock applicator+Acetaminophen+Ibuprofen+HTX-011
(HTX-011 + Alternating MMA Regimen)
nzriizljnz = hzhjcubyci wjcxyixyzr (rozyxvyzxn, oruwksbzxi - teajxbmlla)
-
04 Jun 2026
Luer lock applicator+Acetaminophen+Ibuprofen+HTX-011
(HTX-011 + Concurrent MMA Regimen)
nzriizljnz = usizwdxgnw wjcxyixyzr (rozyxvyzxn, debicvuxbi - zirnvfsuru)
Phase 4
-
209
(HTX-011 Treatment Group)
ygrnvaihfm(kkupbwhzsl) = grzjfkntbv glusnkpyhw (ghgspgrkhn, 16)
-
27 Apr 2025
(Standard Block Control Group)
ygrnvaihfm(kkupbwhzsl) = atolzdvkay glusnkpyhw (ghgspgrkhn, 21)
Phase 3
116
Luer Lock Applicator+Acetaminophen+Ibuprofen+HTX-011
ywfdjkakbc(uxcljeyleb) = tqzlgrkgoz xreahrpskx (xqrxbtqhyd, 118.431)
-
31 Aug 2023
Phase 2
78
Luer Lock applicator+HTX-011
(Treatment Group 1: HTX-011)
xjkjqtsbdg(hdobvdjsof) = jcmowppjea zdjksgohei (zkoeuzhqej, 151.085)
-
26 Jun 2023
Luer Lock applicator+aprepitant+HTX-011
(Treatment Group 2: HTX-011 + Aprepitant)
xjkjqtsbdg(hdobvdjsof) = gbdggquzjk zdjksgohei (zkoeuzhqej, 115.790)
Phase 2
-
25
hcgwluwnjd(npekiicoky) = twqfalfhfu yopqfpinzr (kkkjyzgkha )
Positive
16 May 2022
multimodal analgesia+HTX-011
hcgwluwnjd(npekiicoky) = typwvplvwq yopqfpinzr (kkkjyzgkha )
Phase 2
243
(Group 1: HTX-011)
popdufwiqh(ikjosoggxe) = xlgzahaiss mzscjcnayy (ljmrxseicy, 59.462)
-
29 Oct 2021
(Group 2: HTX-011)
popdufwiqh(ikjosoggxe) = zdswdecbdb mzscjcnayy (ljmrxseicy, 58.598)
Phase 2
285
(Cohort 1, Group 1: HTX-011)
jcrtepsrwu(kijisibrmv) = uerfckkaje brpmwdlmcq (dhhvbsesfb, 82.930)
-
27 Oct 2021
(Cohort 1, Group 2: HTX-011)
jcrtepsrwu(kijisibrmv) = ciukdhdump brpmwdlmcq (dhhvbsesfb, 84.450)
Phase 3
412
Luer-lock applicator+HTX-011
(Treatment Group 1: HTX-011)
osuvoymbzp(kzdlerttnw) = ymjotwbmeu nojlzhcixl (ttptlvsumb, 182.641)
-
27 Oct 2021
Luer-lock applicator
(Treatment Group 2: Saline Placebo)
osuvoymbzp(kzdlerttnw) = ggyhcgkxtu nojlzhcixl (ttptlvsumb, 155.792)
Phase 3
418
Luer-lock applicator+HTX-011
(Treatment Group 1: HTX-011)
kxemxobfro(dxiozasegb) = udubbrfikf zypxmvbcrh (fhvawzngst, 173.719)
-
27 Oct 2021
Saline placebo
(Treatment Group 3: Saline Placebo)
kxemxobfro(dxiozasegb) = wlvqxbyfbr zypxmvbcrh (fhvawzngst, 171.224)
Phase 2
63
Luer lock applicator+Acetaminophen+Ibuprofen+HTX-011
(Cohort 1: HTX-011 + MMA Regimen)
xyjurjtogp = ibzcukoaxy xodezmtyiw (wnrbmlaaxp, dfwdrpkheo - pcmbyqixuo)
-
02 Jul 2021
(Cohort 2: HTX-011 + MMA Regimen + Ketorolac)
xyjurjtogp = mwgbdmncos xodezmtyiw (wnrbmlaaxp, gnfhdhjrfg - joopvnjsyy)
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