Delving into the Latest Updates on Carteolol Hydrochloride/Latanoprost with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Carteolol/latanoprost, Mikeluna

+ [1]

Target

PTGFR x β1-adrenergic receptor x β2-adrenergic receptor

Action

agonists, antagonists

Mechanism

PTGFR agonists(Prostanoid FP receptor agonists), β1-adrenergic receptor agonists(Beta-1 adrenergic receptor agonists), β2-adrenergic receptor antagonists(Beta-2 adrenergic receptor antagonists)

Therapeutic Areas

Eye Diseases

Active Indication

GlaucomaOcular HypertensionGlaucoma, Open-Angle

Inactive Indication-

Originator Organization

Otsuka Pharmaceutical Co., Ltd.

Active Organization

Otsuka Holdings Co., Ltd.

Otsuka Pharmaceutical Co., Ltd.

Teika Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (28 Sep 2016),

GlaucomaOcular Hypertension

Regulation-

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Structure/Sequence

Molecular FormulaC26H40O5

InChIKeyGGXICVAJURFBLW-CEYXHVGTSA-N

CAS Registry130209-82-4

View All Structures (2)

It is a phase III, multi-center, randomized, single-blind (to evaluator), parallel, and positive-controlled clinical trial evaluating the efficacy and safety of OPC-1085EL in the treatment of primary open angle glaucoma or ocular hypertension in Chinese subjects. It is planned that 240 subjects (120 in each group) will be randomly assigned to receive OPC-1085EL or 0.005% latanoprost ophthalmic solution (latanoprost) at a ratio of 1:1.

Start Date27 Sep 2022

Sponsor / Collaborator

Otsuka Beijing Research Institute

CTR20221401

/ Active, not recruitingPhase 3

一项评价OPC-1085EL 滴眼液治疗原发性开角型青光眼或高眼压症中国受试者的有效性及安全性的III期多中心、随机、单盲（评价者盲）、平行、阳性对照临床试验

[Translation] A Phase III multicenter, randomized, single-blind (evaluator-blind), parallel, positive-controlled clinical trial to evaluate the efficacy and safety of OPC-1085EL eye drops in the treatment of primary open-angle glaucoma or ocular hypertension in Chinese subjects

主要目的以原发性开角型青光眼或高眼压症中国受试者为对象，评价OPC-1085EL 滴眼液与0.005％拉坦前列素滴眼液相比的降眼压作用的优效性。次要目的比较OPC-1085EL滴眼液与0.005％拉坦前列素滴眼液使用的安全性。

[Translation]

Primary objective To evaluate the superiority of OPC-1085EL eye drops in lowering intraocular pressure compared with 0.005% latanoprost eye drops in Chinese subjects with primary open-angle glaucoma or ocular hypertension. Secondary objective To compare the safety of OPC-1085EL eye drops and 0.005% latanoprost eye drops.

Start Date27 Sep 2022

Sponsor / Collaborator

Teika Pharmaceutical Co., Ltd.

[+2]

JPRN-UMIN000030288

/ CompletedNot ApplicableIIT

Investigation on the Efficacy and Safety of Carteolol/Latanoprost Combination Ophthalmic Solution to Timolol/Latanoprost Combination Ophthalmic Solution in Patients with Glaucoma - Investigation on the Efficacy and Safety of Carteolol/Latanoprost Combination Ophthalmic Solution in Patients with Glaucoma

Start Date22 Nov 2017

Sponsor / Collaborator-

100 Clinical Results associated with Carteolol Hydrochloride/Latanoprost

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100 Translational Medicine associated with Carteolol Hydrochloride/Latanoprost

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100 Patents (Medical) associated with Carteolol Hydrochloride/Latanoprost

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1

Literatures (Medical) associated with Carteolol Hydrochloride/Latanoprost

01 Nov 2016·American Journal of OphthalmologyQ2 · MEDICINE

Randomized, Controlled, Phase 3 Trials of Carteolol/Latanoprost Fixed Combination in Primary Open-Angle Glaucoma or Ocular Hypertension

Q2 · MEDICINE

Article

Author: Toru Ikegami ; Tetsuya Yamamoto ; Yuji Ishikawa ; Opc El Study Groups ; Satoru Kikuchi

PURPOSETo assess the intraocular pressure (IOP)-lowering effects and safety of a carteolol/latanoprost fixed combination drug (OPC-1085EL) vs latanoprost (Study 1) and carteolol (Study 2) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).DESIGNMulticenter, randomized, evaluator-masked (Study 1)/double-masked (Study 2), parallel-group studies.METHODSSetting: Twenty-eight clinical sites (Study 1) and 19 clinical sites (Study 2) in Japan.STUDY POPULATIONOutpatients with bilateral POAG or OH whose predose IOP was 18 to <35 mm Hg in the study eye after 4 weeks' treatment with latanoprost (Study 1) or carteolol (Study 2) (defined as baseline).INTERVENTIONIn Study 1, 237 patients applied OPC-1085EL (n = 118) or latanoprost (n = 119) for 8 weeks. In Study 2, 193 patients applied OPC-1085EL (n = 78), carteolol (n = 78), or carteolol/latanoprost concomitant therapy (n = 37) for 8 weeks.MAIN OUTCOME MEASUREAdjusted mean IOP reduction at predose from baseline to week 8.RESULTSIn Study 1, the adjusted mean IOP reductions (95% confidence interval [CI]) were 2.9 (2.5-3.3) mm Hg and 1.6 (1.2-2.0) mm Hg in the OPC-1085EL and latanoprost groups, respectively (P < .0001). In Study 2, the adjusted mean IOP reductions (95% CI) were 3.5 (3.1-3.9) mm Hg and 1.6 (1.2-2.0) mm Hg in the OPC-1085EL and carteolol groups, respectively (P < .0001). All adverse drug reactions of OPC-1085EL observed in both studies were mild in severity and only 1 patient in each study discontinued because of an adverse drug reaction.CONCLUSIONSOPC-1085EL is superior to latanoprost or carteolol alone in terms of lowering IOP, and was well tolerated.

100 Deals associated with Carteolol Hydrochloride/Latanoprost

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	S01ED55	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Glaucoma	Japan	Otsuka Holdings Co., Ltd.	28 Sep 2016
Ocular Hypertension	Japan	Otsuka Holdings Co., Ltd.	28 Sep 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glaucoma, Open-Angle	Phase 3	China	Teika Pharmaceutical Co., Ltd.	27 Sep 2022
Glaucoma, Open-Angle	Phase 3	China	Otsuka Pharmaceutical Co., Ltd.	27 Sep 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO2019	Not Applicable	Glaucoma	152	Xalacom	(iuzervkrjw) = helxbswedv lduzghojtr (zdaujyppln )	-	01 Jul 2019
				Duo Trav	(iuzervkrjw) = vnqgpkqwzy lduzghojtr (zdaujyppln )
NCT02105272 (CTgov)	Phase 3	Glaucoma	237	OPC-1085EL ophthalmic solution (OPC-1085EL Ophthalmic Solution)	yokxksavry(tdoawmamqv) = avggyjsihg nytrsqfifs (tmyfrccfjq, gspwtwlxwk - yrspogqefq) View more	-	17 Nov 2015
				Latanoprost ophthalmic solution (Latanoprost Ophthalmic Solution)	yokxksavry(tdoawmamqv) = zaxztycmka nytrsqfifs (tmyfrccfjq, smwbsodrsw - msnqbfzzdh) View more
NCT02105285 (CTgov)	Phase 3	Glaucoma	193	OPC-1085EL ophthalmic solution (OPC-1085EL Ophthalmic Solution)	dgujrwspmr(rnsyfuqvid) = zrcrflwiiw wakuwavamv (hfamwjjtlc, cnpbocyxgb - qyhkkbhtza) View more	-	17 Nov 2015
				Carteolol long-acting ophthalmic solution (Carteolol Long-acting Ophthalmic Solution)	dgujrwspmr(rnsyfuqvid) = kaiugmamuo wakuwavamv (hfamwjjtlc, atrdotoigu - atkrrkpdjg) View more
NCT02108288 (CTgov)	Phase 1	Glaucoma	30	OPC-1085EL ophthalmic solution (OPC-1085EL Ophthalmic Solution)	itmwjsugzx(tvtkqrfzmv) = mhogzidqfm ipxiexgnlp (xvnncfpiog, esfardijwz - ewbhsgdema) View more	-	02 Apr 2015
				Carteolol long-acting ophthalmic solution (Carteolol Long-acting Ophthalmic Solution)	itmwjsugzx(tvtkqrfzmv) = dctwncnroz ipxiexgnlp (xvnncfpiog, wnfarfwktc - fwcaytnvub) View more