Inclusion Criteria:

• Signed informed consent must be obtained prior to any assessment performed (confirm at screening visit)

• Participants aged 18 years or older with confirmed ADPKD diagnosis based on PeiRavine imaging criteria (Akbari et al 2022) from ultrasound, CT, or MRI at any time prior to study start In case of a positive family history:

  • Age between 18 and 39 years, three or more (unilateral or bilateral) renal cysts

  • Age between 40 and 59 years, two cysts in each kidney are sufficient to establish the diagnosis.

  • Age 60 years and above, at least four cysts in each kidney In case of a negative family history:

  • More than 10 cysts in each kidney and exclusion of other cystic disease NOTE: use of CT or MRI for diagnosis In case the diagnosis is made by CT or MRI (instead of ultrasound), the same criteria will be used and only cysts measuring 10 or more millimeters in diameter will be considered to make a diagnosis of ADPKD using these imaging modalities.

• Adult ADPKD patients at risk of progression defined by Mayo Imaging Classification (MIC), as measured by MRI at screening.

Exclusion Criteria:

• Use of tolvaptan, somatostatin analogue, or any approved therapy for the treatment of ADPKD within 3 months of screening

• Any prior exposure to farabursen, or prior enrollment to any other farabursen clinical trial where study drug was taken, including matching placebo

• Any etiology of kidney disease other than ADPKD (e.g. diabetic kidney disease, membranous nephropathy, Alport's disease, etc.) per the Investigator's discretion

• Active confirmed urinary tract infection (UTI) and/or on antimicrobial treatment for UTI at screening

• Active Hepatitis B (HBsAg positive), hepatitis C (HCV RNA positive), or HIV infection (known history of HIV or test positive for HIV antibody at Screening)

• Solitary kidney, anatomical anomalies of the kidney unrelated to ADPKD (e.g. horseshoe kidney) or kidney transplant recipient

• Active malignancy or history of lymphoproliferative disease or malignancy within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or noninvasive malignant colon polyps that have been removed).

• Planned cyst reduction therapy (i.e. - cyst aspiration/drainage, fenestration, sclerotherapy, or partial nephrectomy) in the upcoming two years.

• Use of other investigational drugs within 5 half-lives of screening; or within 30 days (e.g. small molecules including SGLT2i); or until the expected pharmacodynamic effect has returned to baseline (e.g. biologics); whichever is longer; or longer if required by local regulations

• Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg

• Female participants who are pregnant or breastfeeding or intending to conceive during the course of the study.

• Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms). Women of childbearing potential are excluded unless they are using effective methods of contraception during dosing of study treatment.

• Major surgery within 12 weeks prior to screening

• History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.

• Participants that are on blood pressure medication such as renin-angiotensin system inhibitors (RASi), mineralocorticoid antagonist (MRA) and/or Glucagon-like peptide-1 (GLP1) agonists treatments without a stable dose for at least 28 days prior to screening.

• Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3.0 x upper limit of normal (ULN) or total bilirubin ≥ 1.5 x ULN. For patients with known Gilbert’s Syndrome, total bilirubin ≥ 3.0 x ULN.

• Participants with contraindications to MRI including pacemakers, metal fragments, and/or foreign objects

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 03/23/2026. Questions regarding updates should be directed to the study team contact.