Last update 23 Jan 2025

Solifenacin Succinate/Tamsulosin Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
EC-905, JLP-1207, Vesomni
+ [1]
Target
M3 receptor x α1A-AR
Mechanism
M3 receptor antagonists(Muscarinic acetylcholine receptor M3 antagonists), α1A-AR antagonists(Alpha-1a adrenergic receptor antagonists)
Therapeutic Areas
Other Diseases
Active Indication
Lower Urinary Tract Symptoms
Inactive Indication
DysuriaProstatic HyperplasiaUrinary Bladder, Overactive
Originator Organization
Astellas Pharma, Inc.Astellas Pharma, Inc.
Active Organization
Astellas Pharma, Inc.Astellas Pharma, Inc.
Inactive Organization
Astellas Pharma Europe Ltd.
Drug Highest PhaseApproved
First Approval Date
NL (07 Oct 2013),
Lower Urinary Tract Symptoms
Regulation-
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Structure/Sequence

Molecular FormulaC27H32N2O6
InChIKeyRXZMMZZRUPYENV-VROPFNGYSA-N
CAS Registry242478-38-2
View All Structures (2)

Related

11
Clinical Trials associated with Solifenacin Succinate/Tamsulosin Hydrochloride
NCT02494349
/ CompletedPhase 1
Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers.
NCT02447367
/ CompletedPhase 1
Randomized, Open-label, Single Dose, Two-way Crossover, Clinical Trial to Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 After Oral Administration in Healthy Male Volunteers
NCT02180997
/ CompletedPhase 1
Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy Male Volunteers
100 Clinical Results associated with Solifenacin Succinate/Tamsulosin Hydrochloride
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100 Translational Medicine associated with Solifenacin Succinate/Tamsulosin Hydrochloride
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100 Patents (Medical) associated with Solifenacin Succinate/Tamsulosin Hydrochloride
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100 Deals associated with Solifenacin Succinate/Tamsulosin Hydrochloride
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External Link

KEGGWikiATCDrug Bank
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G04CA53
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Lower Urinary Tract Symptoms
NL
Astellas Pharma, Inc.Astellas Pharma, Inc.
07 Oct 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
DysuriaPhase 1
GB
Astellas Pharma Europe Ltd.
01 Apr 2010
Urinary Bladder, OveractivePhase 1
GB
Astellas Pharma Europe Ltd.
01 Apr 2010
Prostatic HyperplasiaPhase 1
NL
Astellas Pharma Europe Ltd.
01 Mar 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NCT01021332 (Neptune II, CTgov)
Phase 3
Prostatic Hyperplasia | Lower Urinary Tract Symptoms
1,067
bruedigzxg(abquknfcyn) = myliacnjya yinhwfffrz (xqwowcsfnb, ylygaitszp - xmizjnnmtw)
View more
-
22 Jan 2016
NCT01018511 (Neptune, CTgov)
Phase 3
Prostatic Hyperplasia | Lower Urinary Tract Symptoms
1,334
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg
(Placebo)
egmmyrvcvn(wcblydfqha) = jqfzspmpca lkfxzxjxjj (kfqaromiho, qqoratcloj - tfkblvegyv)
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-
17 Dec 2015
Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg+tamsulosin hydrochloride OCAS 0.4 mg
(TOCAS 0.4 mg)
egmmyrvcvn(wcblydfqha) = ipocbuvhoq lkfxzxjxjj (kfqaromiho, qnqxoklaaf - wylhdvxykx)
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NCT01021332 (Pubmed | J Urol)
ManualManual
Phase 3
Lower Urinary Tract Symptoms
1,066
solifenacin and tamsulosin oral
tcphhdqwwn(ewrxnipley) = Urinary retention occurred in 13 of 1208 (1.1%) patients receiving one or more FDCs in NEPTUNE and/or NEPTUNE II; 8 (0.7%) required catheterisation (acute urinary retention [AUR]) acwekgqodj (uybxujfjrs )
Positive
01 Feb 2015
NCT01533597 (CTgov)
Phase 4
Urinary Bladder, Overactive
70
(Solifenacin)
hmpewblwrk(ldrlujilsb) = wuhiehemrn bnydnrueba (majqenuosw, wdxedbrpzg - utnixlnkgt)
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-
27 Jan 2015
(Solifenacin Plus Tamsulosin)
hmpewblwrk(ldrlujilsb) = tckcaktunj bnydnrueba (majqenuosw, yykwgyxxwm - kdrsnzalws)
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Approval

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Regulation

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