Ibodutant
Also known as: ACT‑388, BI 135854, ibodutant, MEN15596
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Summary
Ibodutant is a synthetic peptide‑derived NK2 receptor antagonist investigated for the treatment of asthma, chronic obstructive pulmonary disease (COPD) and other inflammatory airway disorders. Development was halted after Phase II/III trials due to insufficient efficacy.
Mechanism of Action
Selective antagonism of the neurokinin‑2 (NK2) receptor, blocking the actions of neurokinin A and reducing bronchoconstriction and neurogenic inflammation.
Routes of Administration
Goals & Uses
- Improvement of stool consistency in IBS-DGastrointestinal Symptom ManagementModerate
- Relief of abdominal pain in IBS-DGastrointestinal Symptom ManagementModerate
- Overall IBS-D symptom responseQuality Of LifeModerate
- COPD symptom reductionRespiratoryModerate
- Reduction of visceral hypersensitivityNociception / Pain ModulationLow
- Asthma controlRespiratoryModerate
Contraindications
- Severe hepatic impairmentOrganModerateLiver function concerns
- Known hypersensitivity to ibodutant or excipientsAllergyHigh
- Known hypersensitivity to ibodutantAllergy/ImmunologyHigh
Adverse Effects
- NasopharyngitisInfectiousUncommon
- Injection site painLocalCommonPain at the injection site
- HeadacheNeurologicCommonPain in the head or upper neck
- NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
- Upper respiratory tract infectionInfectiousUncommon
Drug Interactions
- Concomitant NK2 agonistsModerate
- Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine)Moderate
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)Moderate
Population Constraints
- Male patientsSex BasedRelative
- Pediatric patientsAgeRelative
- Pregnant womenReproductiveRelative
- Children <12 yearsAgeRelative
Regulatory Status
- European UnionInvestigationalClinical trial authorization only; not approved.
- United StatesInvestigationalInvestigational New Drug (IND) status; no FDA approval.
- United KingdomInvestigationalNo marketing authorization; used only in research settings.
Never received marketing authorization; development discontinued in 2016.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Ibodutant?
Ibodutant is a synthetic peptide‑derived NK2 receptor antagonist investigated for the treatment of asthma, chronic obstructive pulmonary disease (COPD) and other inflammatory airway disorders. Development was halted after Phase II/III trials due to insufficient efficacy.
What is Ibodutant used for?
Ibodutant is educationally associated with: Improvement of stool consistency in IBS-D, Relief of abdominal pain in IBS-D, Overall IBS-D symptom response, COPD symptom reduction, Reduction of visceral hypersensitivity, Asthma control. Educational only — not medical advice.
How is Ibodutant administered?
Recorded routes of administration: Intravenous, Oral, Subcutaneous.
What are the potential side effects of Ibodutant?
Reported adverse effects include: Nasopharyngitis, Injection site pain, Headache, Nausea, Upper respiratory tract infection. This list is not exhaustive — consult a qualified clinician.
Who should avoid Ibodutant?
Recorded contraindications: Severe hepatic impairment, Known hypersensitivity to ibodutant or excipients, Known hypersensitivity to ibodutant. Consult a qualified clinician before use.