Deltyba
Authorised
This medicine is authorised for use in the European Union
delamanid
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Deltyba is a medicine that is used in adults, adolescents, children and infants weighing at least 10 kg who have tuberculosis affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, the two standard tuberculosis medicines).
It is used together with other tuberculosis medicines and only when other standard medicines cannot be used either because the disease is resistant to them or because of their side effects.
Deltyba contains the active substance delamanid.
Tuberculosis is rare in the EU, and Deltyba was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 1 February 2008. Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu307524
Deltyba can only be obtained with a prescription and treatment should be started and monitored by a doctor who is experienced in the treatment of multi-drug resistant tuberculosis. It should be used according to official guidelines on treating multi-drug resistant tuberculosis.
The medicine is available as tablets and dispersible tables which are taken with food. The dispersible tablets are only for children and infants weighing between 10 and 30 kg.
Deltyba is taken for 6 months together with other tuberculosis medicines. Treatment with these medicines should continue after Deltyba treatment, as recommended by official guidelines.
For more information about using Deltyba, see the package leaflet or contact a doctor or pharmacist.
Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis (M. tuberculosis). The active substance in Deltyba, delamanid, is an antibiotic active against M. tuberculosis. Although the way it works is unclear, delamanid is known to block the production of methoxy-mycolic and keto-mycolic acids, two essential components of the cell walls of M. tuberculosis, which will cause the bacteria to die.
The effects of Deltyba have been looked at in one main study involving 481 adults with tuberculosis resistant to standard treatments. Patients in the study were given Deltyba or placebo (a dummy treatment) for 2 months in addition to their other treatments. The main measure of effectiveness was the proportion of patients who no longer had the bacteria in their sputum (phlegm). After 2 months of treatment more than 40% of the patients who were taking Deltyba no longer had the bacteria in their sputum compared with 30% of the patients who were taking placebo.
After the main study had finished, patients had the option to receive treatment with Deltyba for 6 months in an extension study. In addition, a majority of patients who entered the main study were followed up for up to 24 months afterwards. Looking at the results of these follow-up studies together, 2 years after starting treatment 75% of patients who received Deltyba for 6 months or more had no bacteria in their sputum compared with 55% of patients who received Deltyba for 2 months or less.
Additional data indicate that the medicine will be as effective in children, including infants, as it is in adults.
Data from further studies, including the end-TB (evaluating newly approved drugs for multidrug resistant TB) study, confirmed the long-term effectiveness and safety of Deltyba.
For the full list of side effects and restrictions with Deltyba, see the package leaflet.
The most common side effects with Deltyba (which may affect more than 1 patient in 10) include nausea, vomiting, headache, sleeping problems, dizziness, gastritis (inflammation of the stomach lining) and decreased appetite.
Deltyba must not be used in patients who have low levels of albumin (a blood protein). It must also not be used in patients who are taking certain other medicines that affect the way Deltyba is broken down in the body.
The European Medicines Agency decided that Deltyba’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency considered that the benefits of Deltyba had been shown for patients with multi-drug resistant tuberculosis affecting the lung. Although the main study was of short duration and the follow-up studies had shortcomings, the Agency considered that the effects shown after the initial 2 months of treatment were likely to be sustained for the full treatment duration. The long-term effectiveness and safety of Deltyba were confirmed by subsequent studies.
The safety profile was considered manageable and several measures were introduced to minimise the risks, including a study to confirm the long-term safety. Furthermore, the medical need for new agents to treat multi-drug resistant tuberculosis was highlighted.
Deltyba was originally given ‘conditional authorisation’. As the company provided the additional data requested by the Agency, the authorisation was switched to standard authorisation.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deltyba have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Deltyba are continuously monitored. Side effects reported with Deltyba are carefully evaluated and any necessary action taken to protect patients.
Deltyba received a conditional marketing authorisation valid throughout the European Union on 28 April 2014. The conditional marketing authorisation was switched to a standard marketing authorisation on 20 February 2026.
Product information
Latest procedure affecting product information:R/0000293774
20/02/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Deltyba
- Active substance
- Delamanid
- International non-proprietary name (INN) or common name
- delamanid
- Therapeutic area (MeSH)
- Tuberculosis, Multidrug-Resistant
- Anatomical therapeutic chemical (ATC) code
- J04AK06
Pharmacotherapeutic group
AntimycobacterialsTherapeutic indication
Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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