Delamanid, sold under the brand name Deltyba, is a medication used to treat
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 ...
.
[ Specifically it is used, along with other ]antituberculosis medication
Tuberculosis management describes the techniques and procedures utilized for treating tuberculosis (TB).
The medical standard for active TB is a short course treatment involving a combination of isoniazid, rifampicin (also known as Rifampin), p ...
s, for active multidrug-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 f ...
.[ It is taken by mouth.]
Common side effects include headache, dizziness, and nausea. Other side effects include QT prolongation
Long QT syndrome (LQTS) is a condition affecting repolarization (relaxing) of the heart after a heartbeat, giving rise to an abnormally lengthy QT interval. It results in an increased risk of an irregular heartbeat which can result in fainting, ...
.[ It has not been studied in pregnancy as of 2016.] Delamanid works by blocking the manufacture of mycolic acid
Mycolic acids are long fatty acids found in the cell walls of the Mycolata taxon, a group of bacteria that includes ''Mycobacterium tuberculosis'', the causative agent of the disease tuberculosis. They form the major component of the cell wall of ...
s thus destabilising the bacterial cell wall
A cell wall is a structural layer surrounding some types of cells, just outside the cell membrane. It can be tough, flexible, and sometimes rigid. It provides the cell with both structural support and protection, and also acts as a filtering mech ...
. It is in the nitroimidazole
5-Nitroimidazole is an organic compound with the formula O2NC3H2N2H. The nitro group at position 5 on the imidazole ring is the most common positional isomer. The term nitroimidazole also refers to a class of antibiotics that share similar chemi ...
class of medications.
Delamanid was approved for medical use in 2014 in Europe, Japan, and South Korea. It is on the World Health Organization's List of Essential Medicines
The WHO Model List of Essential Medicines (aka Essential Medicines List or EML), published by the World Health Organization (WHO), contains the medications considered to be most effective and safe to meet the most important needs in a health ...
. As of 2016 the Stop TB Partnership The Stop TB Partnership was established in 2001 to eliminate tuberculosis as a public health problem. Its 1500 partner organizations include international, nongovernmental and governmental organizations and patient groups. The secretariat is based ...
had an agreement to get the medication for US$1,700 per six month for use in more than 100 countries.
Medical uses
Delamanid is used, along with other antituberculosis medication
Tuberculosis management describes the techniques and procedures utilized for treating tuberculosis (TB).
The medical standard for active TB is a short course treatment involving a combination of isoniazid, rifampicin (also known as Rifampin), p ...
s, for active multidrug-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 f ...
.[
]
Adverse effects
Common side effects include headache, dizziness, and nausea.[ Other side effects include ]QT prolongation
Long QT syndrome (LQTS) is a condition affecting repolarization (relaxing) of the heart after a heartbeat, giving rise to an abnormally lengthy QT interval. It results in an increased risk of an irregular heartbeat which can result in fainting, ...
.[ It has not been studied in pregnancy as of 2016.][
]
Interactions
Delamanid is metabolised by the liver enzyme CYP3A4
Cytochrome P450 3A4 (abbreviated CYP3A4) () is an important enzyme in the body, mainly found in the liver and in the intestine. It oxidizes small foreign organic molecules (xenobiotics), such as toxins or drugs, so that they can be removed from t ...
; therefore strong inducers of this enzyme can reduce its effectiveness.[Pharmazeutische Zeitung]
Delamanid: Neuer Wirkstoff gegen multiresistente TB
, 9 May 2014.
History
In phase II clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
s, the drug was used in combination with standard treatments, such as four or five of the drugs ethambutol
Ethambutol (EMB, E) is a medication primarily used to treat tuberculosis. It is usually given in combination with other tuberculosis medications, such as isoniazid, rifampicin and pyrazinamide. It may also be used to treat ''Mycobacterium avium ...
, 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 l ...
, pyrazinamide
Pyrazinamide is a medication used to treat tuberculosis. For active tuberculosis, it is often used with rifampicin, isoniazid, and either streptomycin or ethambutol. It is not generally recommended for the treatment of latent tuberculosis. It i ...
, rifampicin
Rifampicin, also known as rifampin, is an ansamycin antibiotic used to treat several types of bacterial infections, including tuberculosis (TB), mycobacterium avium complex, ''Mycobacterium avium'' complex, leprosy, and Legionnaires’ disease. ...
, aminoglycoside antibiotic
Aminoglycoside is a medicinal and bacteriologic category of traditional Gram-negative antibacterial medications that inhibit protein synthesis and contain as a portion of the molecule an amino-modified glycoside (sugar). The term can also refer ...
s, and quinolones
Quinolone may refer to:
* 2-Quinolone
* 4-Quinolone
* Quinolone antibiotic
A quinolone antibiotic is a member of a large group of broad-spectrum bacteriocidals that share a bicyclic core structure related to the substance 4-quinolone. They ar ...
. Healing rates (measured as sputum culture conversion
Culture conversion is a diagnostic criteria indicating the point at which samples taken from a person infected with a tuberculosis can no longer produce tuberculosis cell cultures. Culture conversion is a positive prognostic
Prognosis (Greek: Ď ...
) were significantly better in patients who additionally took delamanid.
The European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
(EMA) recommended conditional marketing authorization for delamanid in adults with multidrug-resistant pulmonary tuberculosis without other treatment options because of resistance or tolerability. The EMA considered the data show that the benefits of delamanid outweigh the risks, but that additional studies were needed on the long-term effectiveness.[Drug Discovery & Development]
EMA Recommends Two New Tuberculosis Treatments.
November 22, 2013.
Society and culture
The medication was not readily available globally as of 2015. It was believed that pricing will be similar to bedaquiline
Bedaquiline, sold under the brand name Sirturo, is a medication used to treat active tuberculosis. Specifically, it is used to treat multi-drug-resistant tuberculosis (MDR-TB) along with other medications for tuberculosis. It is used by mouth.
...
, which for six months is approximately US$900 in low income countries, US$3,000 in middle income countries, and US$30,000 in high income countries.[ As of 2016 the ]Stop TB Partnership The Stop TB Partnership was established in 2001 to eliminate tuberculosis as a public health problem. Its 1500 partner organizations include international, nongovernmental and governmental organizations and patient groups. The secretariat is based ...
had an agreement to get the medication for US$1,700 per six month.[
]
References
External links
*
{{Portal bar, Medicine
Anti-tuberculosis drugs
Trifluoromethyl ethers
World Health Organization essential medicines
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