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Olaparib

Phase 3

Epithelial Ovarian Cancer | Small molecule | Oncology |Imunon, Inc.|Last Updated: Aug 4, 2026

Target and mechanism

Molecular targetPARP1, PARP3, PARP2
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

Clinical trial landscape

Olaparib · 1 trial · 4 indications

Phase 3 1
NCT06915025Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal CancerEpithelial Ovarian Cancer
RECRUITING500 Analytics
PHASE3RECRUITING
Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer
Epithelial Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival
48 months

Overall Survival is defined as the time (in months) from the date of randomization to the date of death by any cause.

Secondary Endpoints

Chemotherapy Response Score
12 weeks
Surgical Response
12 weeks
Time to Second Line Treatment
13 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Experimental Arm: IMNN-001 + SOC Chemotherapy + SOC Maintenance TherapyEXPERIMENTALIMNN-001 in combination with standard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy
Control Arm: SOC Chemotherapy + SOC Maintenance TherapyACTIVE_COMPARATORStandard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy.

Interventions

NameTypeDescription
IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer)DRUG100 mg/m2 IP given weekly during frontline treatment
PaclitaxelDRUG175 mg/m2 IV given every 21 days for 6 cycles during frontline treatment
CarboplatinDRUGAUC 6 IV given every 21 days for 6 cycles during frontline treatment
OlaparibDRUGOlaparib (300 mg orally every 12 hours for 2 years) for patients with somatic or germline BRCAmut.
NiraparibDRUGNiraparib (200-300 mg orally daily for 3 years; dosing based on participant's weight and platelet counts) for either HRD/BRCAmut \& HRD/BRCAwt.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Participants must be female, ≥18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent. 2. Participants with a histologically confirmed diagnosis of high-grade non-mucinous epithelial ovarian (serous...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 4, 2026NCT06915025lastUpdatePostDate: changed
LOWAug 4, 2026NCT06915025lastUpdatePostDate: changed
LOWJul 17, 2026NCT06915025lastUpdatePostDate: changed
LOWJul 17, 2026NCT06915025lastUpdatePostDate: changed
LOWJul 17, 2026NCT06915025lastUpdatePostDate: changed
LOWJul 6, 2026NCT06915025lastUpdatePostDate: changed
LOWJul 6, 2026NCT06915025lastUpdatePostDate: changed

Frequently asked questions about Olaparib

What is Olaparib used for in Epithelial Ovarian Cancer?

Olaparib is an investigational small molecule being studied for the treatment of epithelial ovarian cancer. It is currently in Phase 3 clinical development, evaluated in combination with standard neoadjuvant chemotherapy and adjuvant chemotherapy in newly diagnosed patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

What does Olaparib target?

Olaparib targets PARP1, PARP2, and PARP3, which are poly (ADP-ribose) polymerase enzymes. It acts as an inhibitor of these targets, a mechanism being studied in the context of epithelial ovarian cancer treatment.

Who makes Olaparib?

Olaparib is being developed by Imunon, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IMNN. The company is conducting a Phase 3 clinical trial of Olaparib for the treatment of epithelial ovarian cancer.

What phase is Olaparib in?

Olaparib is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 3 trial is recruiting patients to evaluate its safety and efficacy in combination with standard chemotherapy for advanced epithelial ovarian cancer.

What clinical trials is Olaparib in?

Olaparib is being studied in one active Phase 3 clinical trial, identified as NCT06915025. This randomized, active-controlled trial is recruiting 500 female patients aged 18 years and older in the United States with newly diagnosed advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Is Olaparib the same as IMNN-001?

Olaparib is the drug being evaluated in the Phase 3 trial, and the trial title refers to IMNN-001 as the investigational agent. The trial is testing IMNN-001 in combination with standard chemotherapy, and Olaparib is the name associated with this drug candidate in the context of this development program.