Carbachol

Overview

Carbamoylcholine, also known as carbachol, is a muscarinic agonist discovered in 1932. Carbamoylcholine was initially used as a treatment for migraines, induction of diuresis, and other parasympathetic effects. Carbamoylcholine was granted FDA approval on 28 September 1972.

Indication

Carbamoylcholine is indicated to induce miosis for surgery and to reduce intraocular pressure elevations in the first 24 hours after cataract surgery.

Associated Conditions

Acute angle-closure glaucoma
Increased Intra Ocular Pressure (IOP)
Open Angle Glaucoma (OAG)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia	2022/03/08	NCT05270863	Phase 3	Completed	Visus Therapeutics
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia	2021/11/26	NCT05135286	Phase 3	Active, not recruiting	Visus Therapeutics
Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia	2021/03/01	NCT04774237	Phase 2	Completed	Visus Therapeutics
Carbachols Headache-inducing Effect and Changes in Cerebral Blood Flow in Migraine Patients	2007/11/28	NCT00564408	Not Applicable	Completed	Danish Headache Center
Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow	2006/07/28	NCT00357864	N/A	Completed	Danish Headache Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
MIOSTAT	Alcon Laboratories, Inc.	0065-0023	OPHTHALMIC	0.1 mg in 1 mL	6/30/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
MIOSTAT INTRAOCULAR SOLUTION 0.01%	ALCON RESEARCH LLC	SIN04572P	INJECTION	0.01%	6/2/1990

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MIOSTAT carbachol 0.15mg/1.5mL intraocular injection	40624	Alcon Laboratories Australia Pty Ltd	Medicine	A	6/29/1992

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CARBACHOL TAB 2MG	allen & hanburys a glaxo canada ltd. co.	00003212	Tablet - Oral	2 MG / TAB	12/31/1951
CARBASTAT	novartis ophthalmics novartis pharmaceuticals (canada) inc	02195585	Solution - Intraocular	0.01 %	10/22/1996
MIOSTAT OPHTHALMIC LIQ 0.01%	Alcon Canada Inc	00042544	Solution - Intraocular	.01 %	12/31/1980
CARBACHOL INJECTION LIQ SC 0.25MG/ML	bioniche pharma (canada) ltd	02095157	Liquid - Subcutaneous	.25 MG / ML	12/31/1995
CARBACHOL	Mylan Pharmaceuticals ULC	02060043	Tablet - Oral	2 MG	12/31/1995
ISOPTO CARBACHOL 1.5%	Alcon Canada Inc	00000655	Liquid - Ophthalmic	1.5 %	12/31/1951
CARBACHOL INTRAOCULAR SOLUTION 0.01%	sabex inc	02230337	Liquid - Intraocular	0.1 MG / ML	N/A
ISOPTO CARBACHOL 3%	Alcon Canada Inc	00000663	Liquid - Ophthalmic	3 %	12/31/1951

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Tenpoint Therapeutics' BRIMOCHOL™ PF Shows Positive Phase 3 Results for Presbyopia

7 months ago

Tenpoint Therapeutics' BRIMOCHOL™ PF met primary endpoints in the BRIO-II Phase 3 trial, demonstrating statistically significant near vision improvement over 8 hours.

Visus Therapeutics' Brimochol PF Meets Endpoints in Phase 3 Presbyopia Trial

2 years ago

• Visus Therapeutics' Brimochol PF eye drops significantly improved near visual acuity in patients with presbyopia, meeting the primary endpoint in the Phase 3 BRIO-I trial. • The study demonstrated that Brimochol PF achieved a statistically significant gain of at least 15 ETDRS letters in binocular near visual acuity without distance vision loss. • Brimochol PF was well-tolerated, with low headache rates (less than 10%) and no treatment-related serious adverse events reported during the clinical trial. • The company anticipates filing a New Drug Application (NDA) with the FDA in the second half of 2024, following the read-out of the vehicle-controlled BRIO-II study.

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