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  1. pharmadog
  2. ›drugs
  3. ›Crenessity
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crinecerfont

Marketedupdated 3mo ago
by $NBIX NEUROCRINE BIOSCIENCES INC
Approved
community read0 votes

all catalysts(0)

nothing on the calendar yet

Trials studying crinecerfont

  • phase2Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Oldactive not recruitingn=7
  • phase2Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Oldnot yet recruitingn=20
  • phase3Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)active not recruitingn=103
  • phase3Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasiaactive not recruitingn=182
  • phase2Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasiacompletedn=8

Patent cliff

source: FDA Orange Book
first barrier falls
Dec 13, 2029
~3.3 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (16)

  • Jun 9, 2041compositionUS 12128033
  • Jun 9, 2041compositionUS 12128033
  • Jun 9, 2041compositionUS 12128033
  • Jun 9, 2041compositionUS 12128033
  • Jan 21, 2035method-of-use (U-4049)US 10905690
  • Jan 21, 2035method-of-use (U-4049)US 10905690
  • Jan 21, 2035method-of-use (U-4049)US 10905690
  • Jan 21, 2035method-of-use (U-4049)US 10905690
  • Jan 21, 2035method-of-use (U-4049)US 11311544
  • Jan 21, 2035method-of-use (U-4049)US 11311544
  • Jan 21, 2035method-of-use (U-4049)US 11311544
  • Jan 21, 2035method-of-use (U-4049)US 11311544
  • Jan 21, 2035method-of-use (U-4049)US 11730739
  • Jan 21, 2035method-of-use (U-4049)US 11730739
  • Jan 21, 2035method-of-use (U-4049)US 11730739
  • Jan 21, 2035method-of-use (U-4049)US 11730739

FDA exclusivities (8)

  • Dec 13, 2031ODE-503Orphan Drug (7y)
  • Dec 13, 2031ODE-503Orphan Drug (7y)
  • Dec 13, 2031ODE-503Orphan Drug (7y)
  • Dec 13, 2031ODE-503Orphan Drug (7y)
  • Dec 13, 2029NCENew Chemical Entity (5y)3.3y
  • Dec 13, 2029NCENew Chemical Entity (5y)3.3y
  • Dec 13, 2029NCENew Chemical Entity (5y)3.3y
  • Dec 13, 2029NCENew Chemical Entity (5y)3.3y

News(2)

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    biospace · 11d ago
  • Vertex to acquire Crinetics in $10B foray into endocrine disease drugs
    Vertex claimed the two drugs in the deal could eventually bring in more than $5 billion annually. Still, the high price it paid stirred debate among analysts and investors.
    biopharma_dive · 1mo ago
brand
Crenessity
generic
crinecerfont
indication
Congenital Adrenal Hyperplasia (Adrenogenital Syndrome)
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 17m ago
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