Drug reference

Delamanid

Anti-tuberculosis agent (nitro-dihydro-imidazooxazole) · Antitubercular Agent (MDR-TB)

Also known as Deltyba

START

100 mg PO twice daily with food (in MDR-TB regimen)

TYPICAL MAX

200 mg/day

STOP IF

QTc >500 ms or symptomatic arrhythmia

WATCH

ECG/QTc, electrolytes (K/Mg/Ca), albumin, LFTs

CDSCO approvedATC J04AK06

Dose laddermg/d

Renal dose adjustmenteGFR mL/min/1.73m²

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours

ONSET: 2h · absorption
PEAK: 4.5h · Tmax (fed)
t½: 1.4d · t½
DURATION: 12h · BID

EXCRETION

Albumin/CYP3A4 metabolised; not renal unchanged

route + CYP

INTERACTIONS

2 major

SEVERE in our sources

PREGNANCY

Limited data; use only within an optimised MDR-TB regimen if benefit outweighs risk.

FDA category + note

Top interactionssee all 5 →

Qt Prolonging DrugsSevereDatabaseKimi deep-research + Cla
Strong Cyp3a4 InducersSevereDatabaseKimi deep-research + Cla

Available in India

1 branded formulation. Look up specific brands in the Drugs workspace.

Mechanism

Inhibits mycobacterial methoxy- and keto-mycolic acid synthesis, disrupting cell-wall production; a prodrug activated by mycobacterial F420 coenzyme system, active against Mycobacterium tuberculosis.

Indications

Multidrug-resistant pulmonary tuberculosis (combination regimen)

Dosing

Adult: 100 mg PO twice daily with food for 24 weeks, within a combination MDR-TB regimen.
Pediatric: Weight-banded (e.g., 25–50 mg BID by weight) under specialist care.
Renal adjustment: No adjustment in mild–moderate; caution/limited data in severe.
Hepatic adjustment: Not recommended in moderate–severe hepatic impairment.
Geriatric: Limited data; monitor ECG.
Max dose: 200 mg/day (100 mg twice daily)

Pharmacokinetics

Onset

Antimycobacterial effect over days–weeks

Peak effect

~4–5 h (Tmax, with food)

Duration

~12 h (twice-daily)

Half-life

~30–38 h

Bioavailability

Low; increased ~2.7× with food

Protein binding

>99.5% (albumin)

Metabolism

Plasma albumin then hepatic CYP3A4

Excretion

Not renally excreted unchanged; metabolite-mediated

Contraindications

Serum albumin <2.8 g/dL (increased QT risk)
Concomitant strong CYP3A4 inducers
Hypersensitivity

Side effects

Common

QT prolongationNausea/vomitingHeadacheInsomniaDizzinessPalpitations

Serious

QT-interval prolongation / ventricular arrhythmia
Hypokalaemia-aggravated QT
Severe hypersensitivity

Pregnancy & lactation

Pregnancy

Limited data; use only within an optimised MDR-TB regimen if benefit outweighs risk.

Lactation

Limited data; weigh benefit/risk.

Drug interactions

Qt Prolonging Drugs

Severe

Database

Additive QT prolongation

ECG monitoring; correct electrolytes; weigh combination