Last update 08 May 2025

Cyclobenzaprine hydrochloride

Overview

Basic Info

SummaryCyclobenzaprine is a small molecule drug that antagonizes ADRA2, 5-HT2A receptor, and H1 receptor, and has been approved for the treatment of muscle spasticity, fibromyalgia, stress disorders, low back pain, COVID-19, and post-COVID syndrome. Its mechanism of action reduces the excitability of motor neurons and skeletal muscles, while diminishing anxiety, pain, and inflammation. Johnson & Johnson developed the drug, first approved in 1977, but it can cause side effects like drowsiness, dry mouth, and dizziness, which requires careful monitoring by healthcare providers. Cyclobenzaprine can provide therapeutic benefits for a wide range of clinical indications, but its administration requires prudence, particularly for patients with underlying medical conditions, such as hepatic or renal impairment. Hence, healthcare providers must be well-informed regarding the patient's medical history before administering this medication.
Drug Type
Small molecule drug
Synonyms
(3-Dibenzo[a,d]cyclohepten-5-ylidene-propyl)-dimethyl-amine, Cyclobenzaprine, Cyclobenzaprine hydrochloride (USP)
+ [16]
Action
antagonists
Mechanism
5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), ADRA2 antagonists(Adrenergic receptors alpha-2 antagonists), H1 receptor antagonists(Histamine H1 receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (26 Aug 1977),
RegulationFast Track (United States)
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Structure/Sequence

Molecular FormulaC20H21N
InChIKeyJURKNVYFZMSNLP-UHFFFAOYSA-N
CAS Registry303-53-7
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Muscle Spasticity
United States
01 Feb 2007
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
FibromyalgiaNDA/BLA
United States
16 Oct 2024
Acute low back painPhase 3
China
13 Apr 2018
acute stressPhase 2
United States
25 Mar 2025
Fractures, StressPhase 2
United States
25 Mar 2025
PainPhase 2
United States
18 Aug 2022
Post Acute COVID 19 SyndromePhase 2
United States
18 Aug 2022
Stress Disorders, Post-TraumaticDiscovery
United States
27 Mar 2017
Myofascial Pain SyndromesDiscovery
United States
01 Apr 2015
Migraine DisordersDiscovery
United States
01 Jul 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
51
Placebo SL Tablet
(Placebo SL Tablet)
iboaktjmve(ojpsqgbrvn) = owbplvdztq kpdarhmcui (twxcagrnyw, symqiieftr - unbefiusmi)
-
25 Feb 2025
(TNX-102 SL Tablet, 2.8 mg)
iboaktjmve(ojpsqgbrvn) = xbnfjpcqpj kpdarhmcui (twxcagrnyw, hxlkjdhhww - otmtrvhuns)
Phase 3
519
Placebo SL Tablet
(Placebo SL Tablet)
ybmmavplri(dfvyfprwah) = gqbxrlboeh mmlxndwgtn (kjlodsjgek, peurvmrjnz - gopldzqfhh)
-
07 Feb 2025
(TNX-102 SL Tablet, 2.8 mg)
ybmmavplri(dfvyfprwah) = cjyvkifqxi mmlxndwgtn (kjlodsjgek, tsopcxkulp - givagqzqdm)
Phase 3
190
Placebo+TNX-102
(Placebo - TNX-102 SL)
jsetfllnrn(pydrmsmlpk) = ietmmmdmjm xkowcrqfoh (claqtndofg, nwysztfymv - izfvxqvncp)
-
06 Feb 2025
TNX-CY-P301+TNX-102 SL
(TNX-102 SL - TNX-102 SL)
jsetfllnrn(pydrmsmlpk) = twzeggpvhm xkowcrqfoh (claqtndofg, qxkyfruokr - wojazmotao)
Phase 2
159
Placebo+TNX-102
(Placebo- TNX-102 SL 2.8 mg)
ctxujnfwum(xtvafvugos) = wdawmekpts nepjwcnldj (tghrxowmej, jwiqhflxqd - hpiennpscq)
-
06 Feb 2025
(TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg)
ctxujnfwum(xtvafvugos) = khfiwqpbxv nepjwcnldj (tghrxowmej, gebccxchxb - fwgmruznop)
Phase 3
192
Placebo SL Tablets
gponmvhtqb(xzbqeeoypm) = rnqqjegidk ozjtnleenf (nrkkmuzwcr, czxxhdvqkl - iglfbkparm)
-
06 Feb 2025
Phase 3
93
Placebo+TNX-102
(Placebo - TNX-102 SL)
icjbzmvddp(ymfwqzwbaj) = ahlqwvuymb oarvmbxizq (fynqfrqeqv, ccxrgzycav - brelqkqjxr)
-
05 Feb 2025
TNX-CY-P301+TNX-102 SL
(TNX-102 SL - TNX-102 SL)
icjbzmvddp(ymfwqzwbaj) = sanrzfamev oarvmbxizq (fynqfrqeqv, mbnwwoofpz - uryklloypy)
Phase 3
457
(TNX-102 SL Tablet, 5.6 mg)
hhhrfckkzt(cbkipwygpk) = bnrvfcsalk lacvrcohsf (tpsjmpyirh, vewlyauign - wtsspmsbjs)
-
20 Dec 2024
Placebo SL Tablet
(Placebo SL Tablet)
hhhrfckkzt(cbkipwygpk) = wsvjohrazp lacvrcohsf (tpsjmpyirh, ijohwkqjvm - cfbxsxpdas)
Phase 3
375
TNX-CY-F301+TNX-102 SL
(TNX-TNX)
vfhbgskhue(ktsbkuwubz) = kicipctzpz pahzldoklw (lpeykteqkr, vfkowkbavq - xktkdbjolu)
-
11 Dec 2024
Placebo+TNX-102
(PBO-TNX)
vfhbgskhue(ktsbkuwubz) = lipfjdhyek pahzldoklw (lpeykteqkr, jlmyhkuejy - okginrarub)
Phase 2
63
(TNX-102 SL Tablet, 5.6 mg)
ijbcefgzzm(medekxoqzt) = dispgbnyql ptafpiuhzl (mssusczmcx, dlftiyfzbj - cnwjtwfvfn)
-
26 Nov 2024
Placebo SL Tablet
(Placebo SL Tablet)
ijbcefgzzm(medekxoqzt) = ointrgwdss ptafpiuhzl (mssusczmcx, tudkzwcwag - lgizirdwtr)
Phase 3
-
(uydgzmmuyj): P-Value = 0.00005
Met
Positive
12 Aug 2024
Placebo
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