Alcaftadine

Generic Name: Alcaftadine

Brand Names: Lastacaft

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₁N_₃O

CAS Number: 147084-10-4

Unique Ingredient Identifier: 7Z8O94ECSX

Overview

Alcaftadine is a H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. This drug was approved in July 2010.

Indication

用于2岁以上人群过敏性结膜炎相关性眼部瘙痒的治疗。

Associated Conditions

Allergic Conjunctivitis (AC)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Efficacy of Lastacaft® for the Prevention of Itching Associated With Allergic Conjunctivitis in Korea	2015/09/22	NCT02555761	N/A	Completed	Allergan
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy	2014/12/04	NCT02308501	Phase 4	Completed	ORA, Inc.
AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis	2014/06/11	NCT02161146	Phase 3	Completed	Allergan
AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis	2014/03/10	NCT02082262	Phase 3	Completed	Allergan
Ocular Allergy Treatment Practical Impact Trial	2013/03/11	NCT01808768	Phase 4	UNKNOWN	Starx Research Center, LLC
AGN-229666 for the Treatment of Allergic Conjunctivitis	2012/12/21	NCT01754766	Phase 2	Completed	Allergan
A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis	2012/11/26	NCT01732757	Phase 4	Completed	Allergan
A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis	2011/11/11	NCT01470118	Phase 4	Completed	Allergan
Safety and Efficacy Study of a Eye Drop for Eye Allergy	2009/04/28	NCT00889330	Phase 3	Completed	Vistakon Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
LASTACAFT	Allergan, Inc.	0023-4290	OPHTHALMIC	2.5 mg in 1 mL	11/3/2023
LASTACAFT	Rebel Distributors Corp	42254-288	OPHTHALMIC	2.5 mg in 1 mL	9/30/2010
LASTACAFT	Physicians Total Care, Inc.	54868-6294	OPHTHALMIC	2.5 mg in 1 mL	8/22/2011

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
No HSA approvals found for this drug.

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

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.

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