Open-label Treatment in Cushing's Syndrome

This is a long-term, OLE study of levoketoconazole in subjects with endogenous CS who have
completed one or both parent studies or otherwise potentially qualify for this study, as
defined in the eligibility criteria.

Inclusion Criteria:

1. Completed the Extended Evaluation Phase of Study COR-2012-01 (i.e. M12)

2. Completed the Restoration Phase of Study COR-2017-01 (i.e. RES2)

NOTE: Subjects meeting criteria 1 or 2 above who have had a break in therapy may be
eligible only after discussion with the Medical Monitor. If eligible, such subjects
should resume levoketoconazole at or below the prior therapeutic dose at the
discretion of the Investigator. Prior to resuming treatment with levoketoconazole,
other therapies for Cushing's Syndrome must undergo an appropriate washout period,
with minimum durations as follows:

- Ketoconazole or metyrapone: 2 weeks;

- Dopamine agonists: bromocriptine (2 weeks), cabergoline (8 weeks);

- Octreotide acetate LAR, lanreotide Autogel, pasireotide LAR: 12 weeks;

- Lanreotide SR: 8 weeks;

- Octreotide acetate (immediate release) or short-acting pasireotide: 1 week;

- Mifepristone (RU 486, KORLYM): 4 weeks;

- Megestrol acetate or medroxyprogesterone acetate (and selected other synthetic
progestins): 6 weeks.

3. Currently in a named patient program or other Expanded Access Program receiving
levoketoconazole

4. Were levoketoconazole-naïve prior to entry and received early rescue therapy with
open-label levoketoconazole in Study COR-2017-01.

5. Were levoketoconazole-naïve prior to entry and were enrolled in Study COR-2017-01 in
the Dose Titration and Maintenance Phase when randomization was closed. (NOTE: Such
subjects may continue in Study COR-2017-01 until a therapeutic dose has been
established or until the end of the Dose Titration and Maintenance Phase, whichever
comes first).

Exclusion Criteria:

1. Discontinued levoketoconazole while participating in Study COR-2012-01 or Study
COR-2017-01 or a named patient program or other Expanded Access program, due to safety
or tolerability concerns or lack of efficacy.

2. Scheduled for surgery for treatment of CS or received surgery for treatment of CS
within the 6 weeks prior to Screening.

3. Treated with mitotane within 6 months prior to enrollment.

4. History of malignancy, including adrenal or pituitary carcinomas (other than low-risk,
well-differentiated carcinomas of thyroid, breast or prostate that are very unlikely
to require further treatment in the opinion of the treating physician, or squamous
cell or basal cell carcinoma of the skin).