Clinical Trials

Inclusion Criteria:

- Male and female subjects over 18 years old, inclusive

- Has a known childhood diagnosis of classic CAH due to 21-hydroxylase deficiency based
on genetic mutation in CYP21A2 and/or documented elevated 17-OHP and currently treated
with HC, HC acetate, prednisone, prednisolone, methylprednisolone (or a combination of
the aforementioned GCs)

- Has been on a stable supraphsiologic dose of GC replacement ≥15 mg/day and ≤60 mg/day
in HC equivalents

- For subjects with the salt-wasting form of CAH, subject has been on a stable dose of
mineralocorticoid replacement for ≥1 month before screening

Exclusion Criteria:

- Has a known or suspected diagnosis of any other known form of classic CAH (not due to
21 hydroxylase deficiency)

- Has a history that includes bilateral adrenalectomy or hypopituitarism

- Has a history of allergy or hypersensitivity to Tildacerfont, any of its excipients,
or any other CRF1 receptor antagonist

- Current treatment with dexamethasone as GC therapy for CAH. Prior treatment with
dexamethasone is allowed as long as the transition to an alternative GC regimen (eg,
HC, prednisone, or prednisolone) has resulted in a stable dose of GC replacement for
≥1 month before screening.

- Shows clinical signs or symptoms of adrenal insufficiency

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

Eligibility last updated 1/16/23. Questions regarding updates should be directed to the study team contact.