Rimantadine

Overview

An RNA synthesis inhibitor that is used as an antiviral agent in the prophylaxis and treatment of influenza.

Indication

For the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults.

Associated Conditions

Influenza A Virus Infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer	2023/04/24	NCT05826275	Phase 1	Completed	Toragen, Inc.
Hepatitis C Rimantadine and Antiviral Combination Therapy	2011/08/10	NCT01413490	N/A	Completed	The Leeds Teaching Hospitals NHS Trust
A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers	2010/07/30	NCT01172847	Phase 1	Completed	Hoffmann-La Roche

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Rimantadine Hydrochloride	Carilion Materials Management	68151-2103	ORAL	100 mg in 1 1	5/17/2010
Rimantadine Hydrochloride	STAT Rx USA LLC	16590-202	ORAL	100 mg in 1 1	8/14/2012
Rimantadine Hydrochloride	Amneal Pharmaceuticals of New York LLC	0115-1911	ORAL	100 mg in 1 1	12/31/2023
Rimantadine Hydrochloride	H.J. Harkins Company, Inc.	52959-305	ORAL	100 mg in 1 1	9/12/2011

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.

Related News

Toragen's TGN-S11 Shows Early Promise in HPV-Associated Cancers

10 months ago

• Toragen's Phase 1 trial of TGN-S11 demonstrates a favorable safety profile as a monotherapy and in combination with Keytruda for HPV-associated cancers. • Early drug activity was observed in a subset of patients, with decreases in tumor size and circulating tumor HPV DNA (ctHPV DNA) levels. • In the monotherapy arm, one-third of patients showed drug activity, while two out of three patients in the combination arm exhibited similar responses. • The Phase 1 trial is ongoing, with completion expected by the end of 2024, as researchers continue dose escalation and combination therapy evaluations.

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