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 |