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AUR108

Phase 1

Relapsed Advanced Lymphomas | Small molecule | Oncology |Dr. Reddy's Laboratories Ltd|Last Updated: Apr 17, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05984147A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)PHASE1 RECRUITING 40Oct 19, 2023Aug 30, 2027Apr 17, 202627 India
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Study Endpoints
Primary Endpoints
1. First cycle Dose Limiting Toxicities (DLT)
28 Days

Assess dose limiliting toxicities of AUR108

Safety of AUR108 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0
Through study completion, an average of 1 year

Number of participants with TEAEs

Pharmacokinetics Maximum Concentration (Cmax)
Day 1 and Day 17

Maximum Concentration of AUR108

Pharmacokinetics: Time to Maximum concentration (Tmax)
Day 1 and Day 17

Tmax in hours

Pharmacokinetics: Area under the curve (AUC)
Day 1 and Day 17

Area under the curve (AUC) of AUR108 in h\* ng/mL

Pharmacokinetics: Terminal elimination half-life
Day 17

Terminal elimination half-life of AUR 108 in hours

Maximum concentration (Cmax) administered under fasting/fed condition
Day 8

Compare in fast and fed conditions

Time to Maximum concentration (Tmax) administered under fasting/fed condition
Day 8

Compare Tmax in fast and fed conditions

Area under curve (AUC) administered under fasting/fed condition
Day 8

Compare AUC in fast and fed conditions

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AUR108, 50mg to 300mgEXPERIMENTALCurrently, planned dose levels are 50,90,150,220,300 mg will be administered in 3+/4- regimen.
Interventions
NameTypeDescription
AUR108DRUG3 Days dosing, and 4 days no dose in a week
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: 1. Males or females ≥ 18 years of age 2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 3. Acceptable bone marrow and organ function at screening as described below: 1. ANC ≥ 1000/μL (without WBC growth factor support) 2. Platelet count ≥ 75,000/μL...

Countries:India
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05984147primaryCompletionDate: changed
LOWMay 24, 2026NCT05984147studyFirstPostDate: changed