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Atrasentan

Phase 2

Nephropathy | Small molecule | Metabolic |AbbVie Inc.|Last Updated: May 7, 2019

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02118714Atrasentan Spermatogenesis and Testicular FunctionPHASE2 COMPLETED 20 — — Apr 6, 2015Jul 16, 2018May 7, 201913 United States, Germany +2
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Study Endpoints
Primary Endpoints
Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26
Up to 26 weeks

Percentage of Subjects with a Sperm Concentration \< 15 million per mL by Treatment Week 26. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period.

Secondary Endpoints
Percentage of Participants Who Entered the Observation Period and Did Not Return to Within 15% of Baseline Sperm Concentration or Above During the 52-Week Observational Period
Up to 52 weeks after the Treatment Period
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration
From Week 0 up to Treatment Period Week 26 and Observation Period Week 52
Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility
From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
AtrasentanEXPERIMENTALAtrasentan 0.75 mg administered orally once daily (QD) for 26 weeks
Interventions
NameTypeDescription
AtrasentanDRUGAtrasentan
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Eligibility Criteria
Age Range30 Years — 75 Years
SexMALE
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Males 30 to 75 years of age * Type 1 or 2 diabetes and receiving treatment with at least one anti-hyperglycemic medication and angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARB) (renin-angiotensin system \[RAS\] inhibitor) * Estimated Glomerula...

Countries:United StatesGermanyItalySpain
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Competitive Landscape -Diabetic Nephropathy 8 trials
CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN1PHASE2ALN-ANG3, Evinacumab
DexCom, Inc.DXCM1PHASE3Sotagliflozin
Novartis AG Sponsored ADRNVS1PHASE2Atrasentan
ProKidney Corp. Class APROK2 — Renal Autologous Cell Therapy
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