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atumelnant

Phase 3

Congenital Adrenal Hyperplasia | Small molecule | Rare Disease |Crinetics Pharmaceuticals, Inc.|Last Updated: Jun 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment491
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07144163A Study to Evaluate Atumelnant in Adults With Congenital Adrenal HyperplasiaPHASE3 RECRUITING 150 — — Dec 11, 2025May 1, 2027Jun 4, 202645 United States, Argentina +9
NCT07159841A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)PHASE2 RECRUITING 153 — — Jan 22, 2026Mar 1, 2030May 29, 202633 United States, Argentina +8
NCT06712823An Extension Study to Evaluate Safety and Efficacy in Participants Treated With CRN04894PHASE2 RECRUITING 150 — — Feb 25, 2025Nov 1, 2027Sep 23, 20259 United States, Argentina +4
NCT05907291Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)PHASE2 COMPLETED 38 — — Jul 3, 2023Aug 22, 2025Sep 23, 202527 United States, Argentina +5
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Study Endpoints
Primary Endpoints
Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement.
Week 32
Change from baseline in morning serum androstenedione (A4) (Part A)
Week 8
Percent change from baseline in glucocorticoid (GC) daily dose while serum early morning A4 ≤Upper Limit of Normal (ULN) (Part B)
Week 28
Change from baseline in serum early morning A4 over time (Part C)
Up to Week 260
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation
Week 108
Incidence of glucocorticoid (GC) deficiency / adrenal insufficiency and adrenal crisis
Week 108
Incidence of hospitalizations related to congenital adrenal hyperplasia (CAH)
Week 108
Change from baseline in morning (before 11:00 AM) serum androstenedione (A4) over time
Week 108
Change from baseline in morning (before 11:00) serum androstenedione (A4)
Week 12
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Week 12
Secondary Endpoints
Percent change from baseline of morning pre-GC A4
Week 2
Percent change from baseline of morning pre-GC 17-OHP
Week 32
Proportion of participants with morning pre-GC A4 ≤ ULN who are on physiologic GC replacement
Week 32
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TreatmentEXPERIMENTALAtumelnant tablet, administered orally, once daily for 32 weeks.
PlaceboPLACEBO_COMPARATORMatching placebo, administered orally, once daily for 32 weeks.
Treatment (Part A)EXPERIMENTALOpen-label, semi-sequential cohorts.
Active Treatment (Part B)EXPERIMENTALRandomized, Parallel Arms, Double-Blind
Placebo (Part B)PLACEBO_COMPARATORRandomized, Parallel Arms, Double-Blind
Open-Label Treatment (Part C)EXPERIMENTALOpen-label treatment period for participants entering Part C from Part A and B.
Sequential DoseEXPERIMENTALSequential, open-label, 12-week fixed-dose cohorts.
Interventions
NameTypeDescription
AtumelnantDRUGAtumelnant, tablets, once daily by mouth
PlaceboDRUGPlacebo, tablets, once daily by mouth
atumelnant (CRN04894)DRUGAtumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) receptor antagonist.
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Eligibility Criteria
Age Range18 Years — 74 Years
SexALL
Healthy VolunteersNo
Study Sites45

Inclusion Criteria: 1. Male or female, between ≥18 to \<75 years of age at the time of signing the ICF. 2. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment. 3. Have classic CAH due to 21-OHD confirmed by the Investiga...

Countries:United StatesArgentinaAustraliaAustriaBrazilFranceGermanyItalyPolandSwedenUnited KingdomBelgiumIndia
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07144163lastUpdatePostDate: changed
LOWJun 4, 2026NCT07144163lastUpdatePostDate: changed
LOWJun 4, 2026NCT07144163lastUpdatePostDate: changed
LOWJun 4, 2026NCT07144163lastUpdatePostDate: changed
LOWMay 29, 2026NCT07159841lastUpdatePostDate: changed
LOWMay 29, 2026NCT07159841lastUpdatePostDate: changed
LOWMay 29, 2026NCT07159841lastUpdatePostDate: changed
LOWMay 26, 2026NCT06712823primaryCompletionDate: changed
LOWMay 26, 2026NCT07144163primaryCompletionDate: changed
LOWMay 26, 2026NCT07159841primaryCompletionDate: changed
LOWMay 24, 2026NCT06712823studyFirstPostDate: changed
LOWMay 24, 2026NCT07144163studyFirstPostDate: changed
LOWMay 24, 2026NCT07159841studyFirstPostDate: changed