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Ganfeborole

Phase 1

Tuberculosis | Small molecule | Infectious Disease |GSK plc|Last Updated: Aug 25, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Ganfeborole · 1 trial · 1 indication

Phase 1 1
NCT07784894A Study to Investigate the Repeat-dose Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With Ganfeborole in Female Participants of Non-childbearing PotentialTuberculosis
NOT YET_RECRUITING28 Analytics
PHASE1NOT YET_RECRUITING
A Study to Investigate the Repeat-dose Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With Ganfeborole in Female Participants of Non-childbearing Potential
Tuberculosis
NCT0778489428
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Study Endpoints

Primary Endpoints

Area under the plasma concentration-time curve (AUC(0-tau)) over 24 hours of EE and LNG, after repeat dose, alone and in the presence of Ganfeborole on Day 10
On Day 10 at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
AUC(0-tau) over 24 hours of EE and LNG, after repeat dose, alone and in the presence of Ganfeborole on Day 24
On Day 24 at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Maximum observed concentration (Cmax) of EE and LNG, after repeat dose, alone and in the presence of Ganfeborole on Day 10
On Day 10, at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Cmax of EE and LNG, after repeat dose, alone and in the presence of Ganfeborole on Day 24
On Day 24, at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

Secondary Endpoints

AUC(0-tau) over 24 hours of Ganfeborole in the presence of EE and LNG
On Day 24, at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Cmax of Ganfeborole in the presence of EE and LNG
On Days 16, 22 and 23, at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose for each day, and on Days 24 and 25, at 30 minutes pre-dose and 24 hours post-dose for each day
Time of maximum observed concentration (Tmax) of Ganfeborole in the presence of EE and LNG
On Days 16, 22 and 23, at 30 minutes pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose for each day, and on Days 24 and 25, at 30 minutes pre-dose and at 24 hours post-dose for each day
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Microgynon / Ganfeborole + Microgynon GroupEXPERIMENTALParticipants receive in Treatment Period 1: Microgynon repeat dosing from Day 1 to Day 10, and in Treatment Period 2: Ganfeborole low dose alone on Day 11, and Ganfeborole high dose once daily (OD) from Day 12 to Day 24 combined with Microgynon repeat dosing (OD) from Day 15 to Day 24.

Interventions

NameTypeDescription
GanfeboroleDRUGParticipants receive Ganfeborole orally.
MicrogynonDRUGParticipants receive Microgynon orally.
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Eligibility Criteria

Age Range18 Years to 64 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: 1. Participant is 18 to \<65 years of age, inclusive, at the time of signing the informed consent. 2. Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, lab...

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Competitive Landscape -Tuberculosis 7 trials

CompanyTickerTrialsLead PhaseDrugs
Viatris, Inc.VTRS1PHASE3Bedaquiline
Johnson & JohnsonJNJ1PHASE2Bedaquiline, Background Regimen
BioNTech SE Sponsored ADRBNTX1PHASE1BNT164a1, BNT164b1
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Recent Changes (Last 90 Days)

LOWAug 25, 2026NCT07784894NEW_TRIAL: changed
LOWAug 25, 2026NCT07784894NEW_TRIAL: changed

Frequently asked questions about Ganfeborole

What is Ganfeborole used for?

Ganfeborole is an investigational small molecule being developed for the treatment of tuberculosis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its pharmacokinetics and potential interactions.

Who makes Ganfeborole?

Ganfeborole is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy participants.

What phase is Ganfeborole in?

Ganfeborole is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved for any use. The ongoing Phase 1 trial is designed to study the drug's pharmacokinetics when given with a combined oral contraceptive in healthy female participants.

What clinical trials is Ganfeborole in?

Ganfeborole is being studied in one Phase 1 clinical trial with the identifier NCT07784894. This trial is investigating the repeat-dose pharmacokinetics of a combined oral contraceptive when given alone and in combination with Ganfeborole in female participants of non-childbearing potential. The trial is not yet recruiting and has an enrollment target of 28 participants.

Is Ganfeborole the same as any other drug?

No alternative names for Ganfeborole have been identified. The drug is known by its single name and is being developed by GSK plc. It is a small molecule intended for the treatment of tuberculosis, though it is still in early-stage clinical development.