Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
A Single-arm Safety Study of Subjects Exposed to Ibrexafungerp Whilst Pregnant, Including Infant Outcomes Up to One Year
- Vulvovaginitis, Candidal
- Vulvovaginal Candidiasis
- Candida Infection
- Vaginal Candidiasis
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- GlaxoSmithKline
- Enrolment target
- 100
- Started
- 12 November 2025
- Main results due
- 31 July 2029
- Study sites
- 1
- Registry updated
- 23 September 2026
Can you take part?
- Aged 0 years and over.
- Women only.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: 1. Exposure to ibrexafungerp during pregnancy or if conception is estimated to have occurred within 4 days of the last dose of ibrexafungerp 2. Subject and/or parent/legal representative consents to participate and agrees to the conditions and requirements of the study including the interview schedule/completion of questionnaire and release of medical records * Subject can be identified by the sponsor or HCP, in terms of confirmed pregnancy. A self-reported pregnancy will be considered as confirmed pregnancy if the Urine Pregnancy Test (UPT) result is positive. * A woman can self-enroll in the study or her healthcare provider (HCP), with her consent, can enroll her on her behalf. Exclusion Criteria: 1. Females who were not exposed to safety study medications during pregnancy 2. Refusal to participate in the study 3. An inability to provide an accurate medical history or give informed consent
What this study is about
In the sponsor’s own words, from the registry.
This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.
Study sites(1)
AWINSA
New Delhi, Vasant Vihar, India
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05908682. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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