Table 1.
Regulatory status of medicines for the treatment of hypercortisolism in alphabetical order
| Drug substance (trade name) | Indication(s) | Regulatory Status in Europe | ATC-Code 1 | 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 |
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.