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Table 1 Regulatory status of medicines for the treatment of hypercortisolism in alphabetical order

From: Systemic therapy of Cushing’s syndrome

Drug substance (trade name)

Indication(s)

Regulatory Status in Europe

ATC-Code1

Galenic formulation

Route of administration

Aminoglutethimide (Orimeten®)

Originally approved with the following wording:

Not approved any more

L02BG01

Tablet

Oral

Indication: CS

In some patients < Orimeten > is indicated for preparation of surgery. A long-term administration is possible in case of inoperable patients or in case of recurrence after incomplete adrenalectomy. CS may be due to

- Adrenocortical tumors (adenoma and carcinoma)

- ACTH released from ectopic ACTH syndrome

Cabergoline (Dostinex®)

Parkinson’s disease and hyperprolactinemic disorders

Approved

N04BC06; G02CB03

Tablet

Oral

Etomidate (Hypnomidate®)

Hypnomidate is used for anesthesia

Approved

N01AX07

Solution

Intravenous injection

Ketoconazole (Nizoral®)

Treatment of CS

MAA submitted to the EMA2

J02AB02

Tablet

Oral

Metyrapone (Metopirone®)

- As a diagnostic test for ACTH insufficiency and in the differential diagnosis of ACTH-dependent CS.

Licensed in Ireland, UK, France based on national procedures

V04CD01

Capsule

Oral

- For the management of patients with CS.

Trade name: Metopirone®

Mifepristone (Corluxin®)

Treatment of CS secondary to ectopic ACTH secretion

Not yet approved in CS3

G03XB01

Tablet

Oral

MAA submitted to EMA

Mitotane (Lysodren®)

Symptomatic treatment of advanced (non-resectable, metastatic or recurrent) adrenal carcinoma

Licensed via central procedure as orphan drug since 2004

L01XX23

Tablet

Oral

Trade name: Lysodren® (EMEA/H/C/000521)

Pasireotide (Signifor®)

Second-line treatment of CD in patients where surgery has failed

Licensed via central procedure as orphan drug since 2012

H01CB05

Solution and powder for solution for injection, respectively

Subcutaneous injection

Trade name: Signifor®

Rosiglitazone (Avandia®)

Rosiglitazone is used to treat type 2 diabetes mellitus, particularly those who are overweight. It is used in addition to diet and exercise

Currently suspended for use in the European Union, restricted use in the US

A10BG03

Tablet

Oral

Temozolomide (Temodal®)

Off-label in aggressively growing pituitary macroademomas

Licensed (initially via central procedure) for Glioblastoma multiforme and anaplastic astrocytoma since 1999 (EMEA/H/C/000229)

L01AX03

Capsule

Oral

  1. Abbreviations: CD, Cushing’s disease; CS, Cushing’s syndrome; EMA, European Medicines Agency; MAA, marketing authorization application; 1If off-label use, ATC-Code from other indication is depicted; 2in anti-fungal (Nizoral®) indication marketing authorization is suspended in Europe due to hepatotoxicity; 3for abortion, licensing status is varying among European Member States.