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Date: 2018-09-27

Type of information: Granting of the orphan status in the US

Product name: relacorilant (CORT125134)

Compound: relacorilant

Therapeutic area: Cancer - Oncology

Action mechanism: glucocorticoid receptor antagonist

Company: Corcept Therapeutics (USA - CA)

Disease: pancreatic cancer

Latest news:

  • • On September 27, 2018, the FDA has granted orphan drug status to Corcept’s selective cortisol modulator relacorilant to treat patients with pancreatic cancer. Corcept is conducting clinical trials of relacorilant in combination with nab-paclitaxel (Abraxane®) as a treatment for pancreatic cancer and other solid tumors.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA: 2018-09-27

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes