SQ109 is a drug undergoing development for treatment of

tuberculosis Tuberculosis (TB) is an infectious disease usually caused by ''Mycobacterium tuberculosis'' (MTB) bacteria. Tuberculosis generally affects the lungs, but it can also affect other parts of the body. Most infections show no symptoms, in w ...

Background

On October 16, 2007, it was given the status of

Orphan drug An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment o ...

by the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(FDA) for use against drug-susceptible and

drug-resistant Drug resistance is the reduction in effectiveness of a medication such as an antimicrobial or an antineoplastic in treating a disease or condition. The term is used in the context of resistance that pathogens or cancers have "acquired", that is, ...

TB bacteria. SQ109 completed three phase I studies in the U.S. and one Phase II efficacy studies in tuberculosis patients in Africa. SQ109 showed activity against both drug susceptible and

multi-drug-resistant tuberculosis Multidrug-resistant tuberculosis (MDR-TB) is a form of tuberculosis (TB) infection caused by bacteria that are resistant to treatment with at least two of the most powerful first-line anti-TB medications (drugs): isoniazid and rifampin. Some ...

bacteria, including

extensively drug-resistant tuberculosis Extensively drug-resistant tuberculosis (XDR-TB) is a form of tuberculosis caused by bacteria that are resistant to some of the most effective anti-TB drugs. XDR-TB strains have arisen after the mismanagement of individuals with multidrug-resis ...

strains. In preclinical studies SQ109 enhanced the activity of anti-tubercular drugs

isoniazid Isoniazid, also known as isonicotinic acid hydrazide (INH), is an antibiotic used for the treatment of tuberculosis. For active tuberculosis it is often used together with rifampicin, pyrazinamide, and either streptomycin or ethambutol. For ...

and

rifampin Rifampicin, also known as rifampin, is an ansamycin antibiotic used to treat several types of bacterial infections, including tuberculosis (TB), ''Mycobacterium avium'' complex, leprosy, and Legionnaires’ disease. It is almost always used ...

and reduced by >30% the time required to cure mice of experimental TB. SQ109 is being developed by OOO Infectex in

Russia Russia (, , ), or the Russian Federation, is a transcontinental country spanning Eastern Europe and Northern Asia. It is the largest country in the world, with its internationally recognised territory covering , and encompassing one-eigh ...

and by Sequella Inc internationally. In July 2012, Infectex received notification from the Russian Ministry of Health for approval to begin the pivotal clinical trial associated with a drug registration submission, and can proceed with the clinical development of SQ109 for treatment of tuberculosis in the Russian Federation.

References

Adamantanes Anti-tuberculosis drugs Russian inventions Secondary amines Dienes {{antiinfective-drug-stub

Background

See also

References