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AUR108

Phase 1

Relapsed Advanced Lymphomas | Small molecule | Oncology |Dr. Reddy's Laboratories Ltd|Trials Updated: Apr 17, 2026

AUR108 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2023

AUR108 target and mechanism

Molecular targetDHODH
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

AUR108 clinical trials

AUR108 · 1 trial · 1 indication

Phase 1 1
NCT05984147A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)Relapsed Advanced Lymphomas
RECRUITING40 Analytics
PHASE1RECRUITING
A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)
Relapsed Advanced LymphomasUnlock trial analytics

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 to 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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Frequently asked questions about AUR108

What is AUR108 used for in relapsed advanced lymphomas?

AUR108 is an investigational small molecule being studied for the treatment of relapsed advanced lymphomas. It is currently in Phase 1 clinical development, with an ongoing trial evaluating its safety and efficacy in patients with this condition.

What does AUR108 target?

AUR108 targets dihydroorotate dehydrogenase (DHODH), an enzyme involved in pyrimidine synthesis. By inhibiting DHODH, the drug aims to disrupt cellular processes relevant to cancer cell proliferation in relapsed advanced lymphomas.

Who is developing AUR108?

AUR108 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting clinical trials for this investigational oncology drug.

What phase is AUR108 in?

AUR108 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients to evaluate its safety and efficacy.

What clinical trials is AUR108 in?

AUR108 is being studied in a Phase 1 clinical trial with the identifier NCT05984147, titled 'A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)'. This trial is recruiting participants in India and aims to enroll 40 patients.