PARP1 inhibitors(Poly (ADP-Ribose) polymerase 1 inhibitors), PARP2 inhibitors(Poly (ADP-Ribose) Polymerase 2 inhibitors), PARP3 inhibitors(Poly (ADP-Ribose) Polymerase 3 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [10]

Active Indication

Advanced Endometrial CarcinomaRecurrent Endometrial CancerBRCA mutation positive Breast Cancer+ [139]

Inactive Indication

Advanced Cervical CarcinomaAdvanced gastric carcinomaAdvanced Lung Non-Small Cell Carcinoma+ [33]

Originator Organization

AstraZeneca PLC

Active Organization

Merck Sharp & Dohme Corp.

AstraZeneca PLCAbbVie Ltd. (United Kingdom)

+ [14]

Inactive Organization

Syndax Pharmaceuticals, Inc.

License Organization

Breast International Group

+ [1]

Drug Highest PhaseApproved

First Approval Date

European Union (16 Dec 2014),

BRCA Mutation Castration-Resistant Prostate CancerBRCA-mutated Fallopian Tube CarcinomaBRCA-mutated Ovarian Cancer+ [12]

RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Conditional marketing approval (China), Orphan Drug (Japan), Priority Review (Australia), Accelerated Approval (Canada), Priority Review (China), Special Review Project (China)

Structure/Sequence

Molecular FormulaC24H23FN4O3

InChIKeyFDLYAMZZIXQODN-UHFFFAOYSA-N

CAS Registry763113-22-0

503

Clinical Trials associated with Olaparib

NCT06856499

/ Not yet recruitingPhase 1IIT

Phase I Evaluation of Combination CLK/DYRK (Cirtuvivint) Inhibition With PARP Inhibition (Olaparib) in BRCA/HRD Platinum Resistant Ovarian Cancer

The purpose of this study is to learn about the safety and tolerability of Cirtuvivint in combination with Olaparib in platinum resistant ovarian cancer. The study also aims to determine the recommended dose of the combination therapy.
If a participant is a good fit for the study, and they enroll in the study, they will:
* Visit the clinic often at the beginning of the study for physical exams, blood draws, vital signs, and other study and routine care procedures. After the first two months participants will visit the clinic every 28 days.
* Take the study medications, Cirtuvivint and Olaparib. Participants will take Olaparib every day. Participants will either take Cirtuvivint 5 days per week or 2 days per week.

Start Date01 Dec 2025

Sponsor / Collaborator

University of Colorado Denver

[+2]

NCT05128734

/ Not yet recruitingPhase 2IIT

A Randomized Phase II Study of Temozolomide Monotherapy or in Combination With Olaparib in Patients With METHYLATED 06-Methylguanine-DNA Methyltransferase (MGMT) Pre-Treated Triple Negative Breast Cancer (TNBC)

This is a randomized phase II study to evaluate the disease control rate (DCR) of patients with metastatic or locally advanced METHYLATED 06-methylguanine-DNA methyltransferase (MGMT) with triple-negative breast cancer (TNBC) treated with Temozolomide ± Olaparib. Patients will be randomized 1:1 to Treatment Arm 1 (temozolomide treatment) or Arm 2 (temozolomide plus olaparib treatment).

Start Date01 Sep 2025

Sponsor / Collaborator

AHS Cancer Control Alberta

NCT07024784

/ Not yet recruitingPhase 2

A Phase 1b Dose Escalation and Expansion Study of IMGN151 as Monotherapy and in Combination With Other Anti-Cancer Therapies in Subjects With Gynecologic Cancers

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety and tolerability of IMGN151 when given as monotherapy and in combination with other anti-cancer therapies in adult participants with gynecologic cancers.
IMGN151 is an investigational drug being developed for the treatment of gynecologic cancers. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Around 350 participants with gynecologic cancers will be enrolled in the study at approximately 50 sites worldwide.
Participants will receive intravenous infusions of IMGN151 as monotherapy or in combination with anti-cancer therapies according to their assigned study arm. In Arm A, participants will receive IMGN151 in combination with carboplatin on Day 1 of each cycle. In Arm B, participants will receive IMGN151 in combination with olaparib, twice a day (BID) on Day 1 of each cycle. In Arm C, participants will receive IMGN151 in combination with bevacizumab on Day 1 of each cycle. In Arm D, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. The total study duration will be approximately 3 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Start Date15 Jul 2025

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Olaparib

100 Translational Medicine associated with Olaparib

100 Patents (Medical) associated with Olaparib

4,853

Literatures (Medical) associated with Olaparib

31 Dec 2025·INTERNATIONAL JOURNAL OF HYPERTHERMIA

Addition of PARP1-inhibition enhances chemoradiotherapy and thermoradiotherapy when treating cervical cancer in an in vivo mouse model

Article

Author: van Bochove, Gregor G. W. ; Rodermond, Hans M. ; Oei, Arlene L. ; Krawczyk, Przemek M. ; Stalpers, Lukas J. A. ; Franken, Nicolaas A. P. ; Scutigliani, Enzo M. ; Mei, Xionge ; Crezee, Johannes ; IJff, Marloes

Background: Efficacy of current treatment options for cervical cancer require improvement. Previous in vitro studies have shown the enhancing effects of the addition of PARP1-inhibitors to chemoradiotherapy and thermoradiotherapy. The aim of our present study was to test efficacy of different combinations of treatment modalities radiotherapy, cisplatin, hyperthermia and PARP1-inhibitors using in vitro tumor models, ex vivo treated patient samples and in vivo tumor models.Materials and Methods: In vitro clonogenic survival curves (0-6 Gy) show that PARP1-i (4-5 M Olaparib) enhances both chemoradiotherapy (0.3-0.5 µM cisplatin) and thermoradiotherapy (42 °C for 1 h) in SiHa, CaSki and HeLa cells. A cervical cancer mouse model and freshly obtained in-house developed patient-derived organoids were used to examine the effects of different treatment combinations. For the in vivo study, human cervical cancer (SiHa) cells were injected in the right hind leg of athymic nude mice. In vivo mouse experiments show that PARP1-i enhances thermoradiotherapy or chemoradiotherapy by reduction of tumor volumes. Five cycles of treatment were applied with the following doses per cycle: irradiation 3 Gy, hyperthermia 1 h at 42 °C, cisplatin at 2 mg/kg, and twice PARP1-i at 50 mg/kg.Results: Quadruple treatment, combining radiotherapy, hyperthermia, cisplatin and PARP1-i, was very effective but also lead to severe side effects causing severe weight loss and death. In contrast, thermoradiotherapy or chemoradiotherapy with addition of PARP1-i, were effective without serious side effects.Conclusion: The triple combinations are promising options for potentially more effective treatment of locally advanced cervical cancer without more toxicity.

31 Dec 2025·ANNALS OF MEDICINE

Haematologic outcomes and associated clinical characteristics among patients receiving Olaparib therapy in the UAE: a retrospective chart review

Article

Author: Akour, Amal ; Nabil, Said ; Ibrahim, Mariam ; Kendakji, Saba ; ZainAlAbdin, Sham ; Aburuz, Salahdein ; Wahba, Lina

BACKGROUND:

Poly ADP ribose polymerase (PARP) inhibitors, such as Olaparib (Lynparza^®), are pivotal in treating certain cancers, particularly those linked to BReast CAncer gene (BRCA) mutations. Despite its established efficacy, Olaparib use is associated with various adverse events (AEs), notably haematologic toxicities, such as anaemia. This retrospective chart review study aimed to examine haematologic outcomes and associated factors in patients treated with Olaparib at a tertiary hospital in the UAE.

METHODS:

We reviewed the medical charts of patients prescribed Olaparib and focused on haematologic indices at a baseline of 1-month, 3-month and 6-month follow-up periods. Data were analysed to determine the AEs frequency, transfusions need and potential associated patients' clinical characteristics.

RESULTS:

This study included all patients who received Olaparib (n = 66). Most patients were females (n = 61; 92.4%) and the vast majority were non-smokers (97%) and free of hepatic disease. Themean age of the patients was 57.03-year-old (SD) = 12.06 years), and body mass index (BMI) was 28.16 (SD = 6.40) kg/m². A high rate of anaemia (70.8%) was detected among the patients during their Olaparib therapy. Approximately, one-third of the patients developed neutropenia and thrombocytopenia. Transfusion was needed in almost half of the patients. Glomerular filtration rate (GFR) and neutropenia were significantly correlated with moderate-severe anaemia (OR = 0.097, 95% CI: 0.011-0.88, p value = .038) and (OR = 9.04, 95% CI: 1.024-79.78, p value = .048), respectively.

CONCLUSIONS:

Our findings highlight the side effects of Olaparib therapy in terms of haematology which could be avoided. Further studies are needed to better understand the therapeutic management of Olaparib and the mitigation of haematologic complications.

01 Oct 2025·COMPUTATIONAL BIOLOGY AND CHEMISTRY

The drug discovery candidate for targeting PARP1 with Onosma. Dichroantha compounds in triple-negative breast cancer: A virtual screening and molecular dynamic simulation

Article

Author: Mishra, Anurag ; Chandra, Muktesh ; Hamad, Atheer Khdyair ; Jawad, Mahmood Jasem ; Taher, Waam Mohammed ; Kareem, Radhwan Abdul ; Verma, Lokesh ; Prasad, G V Siva ; Alwan, Mariem ; Ahmed, Hanan Hassan ; Saadh, Mohamed J

Triple-negative breast cancer (TNBC) is an aggressive subtype characterized by the overexpression of poly-ADP ribose polymerase 1 (PARP1), a key enzyme in DNA repair. Targeting PARP1 with inhibitors presents a promising therapeutic strategy, particularly given the limited treatment options for TNBC. This study employed in silico methodologies to evaluate the pharmacokinetic and inhibitory potential of FDA-approved drugs and compounds derived from Onosma. dichroantha root extracts against PARP1. Virtual screening and molecular docking identified Midazolam, Olaparib, Beta-sitosterol, and 1-Hexyl-4-nitrobenzene as top candidates, exhibiting strong binding affinities of -10.6 kcal/mol, -9.9 kcal/mol, -6.83 kcal/mol, and -5.53 kcal/mol respectively. Molecular dynamics simulations (MDS) over 100 nanoseconds revealed that Beta-sitosterol formed the most stable complex with PARP1, demonstrating minimal structural deviations and robust hydrogen bonding. The Molecular Mechanics-Poisson-Boltzmann Surface Area (MM-PBSA) analysis further confirmed Beta-Sitosterol and Olaparib superior binding free energy (ΔG_bind= -175.43 kcal/mol and -180.8 kcal/mol respectively), highlighting its potential as a potent PARP1 inhibitor. ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) profiling indicated that Beta-Sitosterol adheres to Lipinski's Rule of Five, with high intestinal absorption (95.88 %) and blood-brain barrier permeability (0.824), despite low water solubility. Protein-protein interaction analysis identified key PARP1-associated proteins, including CASP3, CASP7, and XRCC1, suggesting broader therapeutic implications. These findings underscore the potential of Beta-Sitosterol as a novel PARP1 inhibitor for TNBC treatment, combining computational validation with favorable pharmacokinetic properties. The study also highlights the utility of drug repurposing and plant-derived compounds in developing targeted therapies for TNBC, paving the way for further preclinical and clinical investigations.

669

News (Medical) associated with Olaparib

30 Jun 2025

·www.einpresswire.com

January - March 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

ELEVIDYS (delandistrogene moxeparvovec-rokl) Hepatotoxicity-associated fatalities in non-ambulatory patients with Duchenne muscular dystrophy FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on June 24, 2025: FDA Investigating Deaths Due to Acute Liver Failure in Non-ambulatory Duchenne Muscular Dystrophy Patients Following ELEVIDYS Finasteride (compounded product) topical Adverse event FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride products Janus kinase (JAK) inhibitors Cerebral venous sinus thrombosis FDA is evaluating the need for regulatory action. Leqembi (lecanemab-irmb) injection Amyloid related imaging abnormality-edema/effusion FDA is evaluating the need for regulatory action. Ocaliva (obeticholic acid) tablets Liver disorder FDA is evaluating the need for regulatory action. Olanzapine-containing products Lybalvi (olanzapine and samidorphan) tablets Symbyax (olanzapine and fluoxetine) capsules Zyprexa (olanzapine) tablets Zyprexa Intramuscular (olanzapine) injection Zyprexa Relprevv (olanzapine) injectable suspension Zyprexa Zydis (olanzapine) tablets Inappropriate antidiuretic hormone secretion FDA is evaluating the need for regulatory action. Poly (ADP-ribose) polymerase (PARP) inhibitors Akeega (niraparib and abiraterone acetate) tablets Lynparza (olaparib) tablets Rubraca (rucaparib) tablets Talzenna (talazoparib) capsules Zejula (niraparib) tablets Vasculitis FDA is evaluating the need for regulatory action. Rilutek (riluzole) tablets Tiglutik (riluzole) oral suspension Pancreatitis acute FDA is evaluating the need for regulatory action. Suprep Bowel Pre Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution Hypersensitivity FDA is evaluating the need for regulatory action. Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection Severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy FDA is evaluating the need for regulatory action. Xcopri (cenobamate tablets) Drug-induced liver injury FDA is evaluating the need for regulatory action. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

11 Jun 2025

·www.prnewswire.com

Kazia Therapeutics Announces Transformative Preclinical Data Demonstrating Paxalisib's Potential to Overcome Immunotherapy Resistance in Triple-Negative Breast Cancer (TNBC)

SYDNEY, June 11, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a clinical-stage biotechnology company pioneering next-generation oncology therapeutics, today announced the publication of transformative preclinical research in the journal Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research that underscores the powerful potential of its lead asset, paxalisib, in reshaping the treatment landscape for triple-negative breast cancer (TNBC), one of the most aggressive and treatment-resistant cancer subtypes. The preclinical program was conducted by Professor Sudha Rao at the renowned QIMR Berghofer Medical Research Institute, revealing how paxalisib can reprogram the tumor microenvironment and enhance immune response, showing substantial synergy with immune checkpoint inhibitors. The data provide strong scientific and translational rationale for continued development of paxalisib as part of immunotherapy-based regimens. Key Findings Dual targeting of PI3K and mTOR but not PI3K alone inhibits cancer cell proliferation and migration in vitro. Paxalisib remodels the TNBC tumor microenvironment, increasing CD4+ and CD8+ T cell infiltration and activation The combination of paxalisib with KEYTRUDA® (pembrolizumab) demonstrated synergistic antitumor activity in advanced breast cancer, resulting in robust tumor regression and prolonged survival in preclinical models The data validate a mechanistic rationale for ongoing clinical exploration of paxalisib in combination with checkpoint inhibitors and PARP inhibitors "This landmark study offers a mechanistic and translational foundation for our newly launched Phase 1b clinical trial of paxalisib in advanced breast cancer," said Dr. John Friend, CEO of Kazia. "It not only extends the therapeutic potential of paxalisib beyond brain cancers but also positions it at the forefront of innovative immunotherapy combinations in solid tumors." The publication, "Combination of the PI3K/mTOR inhibitor paxalisib with immune checkpoint inhibitors enhances antitumor activity in preclinical models of triple-negative breast cancer," is available online at . Clinical Milestone Kazia recently announced that the first patient has been dosed in the Phase 1b trial evaluating paxalisib in combination with checkpoint inhibitors and chemotherapy in advanced breast cancer, marking a critical step toward clinical translation of these findings. For investor and media, please contact Alex Star, Managing Director LifeSci Advisors LLC About Kazia Therapeutics Limited Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, an investigational brain penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2/3 study in glioblastoma (GBM-Agile) was reported in 2024 and discussions are ongoing for designing and executing a pivotal registrational study in pursuit of a standard approval. Other clinical trials involving paxalisib are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these trials having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018, and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. A Phase I study has been completed and preliminary data was presented at 15th Biennial Ovarian Cancer Research Symposium in September 2024. For more information, please visit or follow us on X @KaziaTx. Forward-Looking Statements This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials, Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801, the potential results of its Phase 1b clinical trial evaluating paxalisib in combination with olaparib or KEYTRUDA® (pembrolizumab), developed by Merck & Co., Inc. for patients with advanced breast cancer, the potential benefits of paxalisib as an investigational PI3K/mTOR inhibitor, timing for any regulatory submissions or discussions with regulatory agencies, the potential market opportunity for paxalisib and Kazia's intent and efforts to regain and/or maintain compliance with the applicable Nasdaq continued listing requirements and standards. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, related to the impact of global economic conditions, and related to Kazia's ability to regain and/or maintain compliance with the applicable Nasdaq continued listing requirements and standards. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the SEC, and in subsequent filings with the United States Securities and Exchange Commission. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement. This announcement was authorized for release by Dr. John Friend, CEO. SOURCE Kazia Therapeutics Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Fast TrackPhase 1Orphan DrugImmunotherapyAACR

05 Jun 2025

·www.prnewswire.com

Kazia Therapeutics Announces First Patient Dosed in Phase 1b Trial of Paxalisib in Advanced Breast Cancer

Trial is expected to provide key insights on how paxalisib therapy can be combined with established immunotherapies and standard of care chemotherapy to improve patient outcomes in advanced breast cancer SYDNEY, June 5, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused biotechnology company developing innovative therapies for difficult-to-treat cancers, today announced that the first patient has been dosed in a Phase 1b clinical trial sponsored by Kazia. The study evaluates paxalisib, the Company's dual PI3K/mTOR inhibitor, in combination with olaparib or pembrolizumab for patients with advanced breast cancer. This multi-center, open-label, randomized trial is designed to assess the safety, tolerability, and preliminary efficacy of multiple paxalisib-based treatment combinations. The study also includes deep biomarker profiling to support future development and early signals of clinical activity. "The start of patient dosing in this Kazia-sponsored study marks an important milestone in the evolution of paxalisib beyond brain cancer and into broader solid tumor applications," said Dr. John Friend, Chief Executive Officer of Kazia. "By leveraging the dual inhibition of PI3K and mTOR, this trial builds on compelling preclinical data showing epigenetic modulation in aggressive breast cancer pre-clinical models. We believe the combinations explored here may provide a more effective therapeutic strategy by simultaneously targeting tumor metabolism, DNA repair, and immune evasion." About the Study This Phase 1b trial (ACTRNXXX) will enroll patients with advanced breast cancer into two treatment arms: Arm A: Patients are randomized to receive either 15mg or 30mg of paxalisib (once daily) in combination with olaparib (300mg orally, twice daily), administered in 28-day cycles. Arm B: Patients are randomized to receive paxalisib (15mg or 30mg once daily) and pembrolizumab (200mg IV every 21 days) alongside standard-of-care chemotherapy: either nanoparticle albumin-bound paclitaxel or a gemcitabine-carboplatin regimen, depending on clinical indication. Participants will be evaluated for: Adverse events and overall tolerability Changes in circulating tumor cells ("CTCs") and CTC clusters Immune cell signatures and overall immune function Clinical activity and tumor response signals Strategic Significance For investors, this trial expands the clinical footprint of paxalisib into solid tumors beyond the central nervous system, targeting a significant commercial opportunity in advanced and metastatic breast cancers, including triple-negative breast cancer. For potential partners and acquirers, the novel biomarker-driven design provides an early window into how paxalisib may enhance or sensitize tumors to immune checkpoint inhibitors and DNA repair-targeted therapy. For the scientific community, the study is structured to generate translational data that may clarify the mechanistic interactions between dual PI3K/mTOR inhibition, immune modulation, and chemotherapy-induced cytotoxicity. "The integration of paxalisib into combination regimens reflects our strategy of building value through differentiated science and high-quality collaborations," added Dr. Friend. "As this study progresses, we aim to share interim updates that may further underscore the potential of paxalisib to impact multiple indications with poor prognoses." For investor and media, please contact Alex Star, Managing Director LifeSci Advisors LLC About Kazia Therapeutics Limited Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, an investigational brain penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2/3 study in glioblastoma (GBM-Agile) was reported in 2024 and discussions are ongoing for designing and executing a pivotal registrational study in pursuit of a standard approval. Other clinical trials involving paxalisib are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these trials having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018, and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. A Phase I study has been completed and preliminary data was presented at 15th Biennial Ovarian Cancer Research Symposium in September 2024. For more information, please visit or follow us on X @KaziaTx. Forward-Looking Statements This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials, Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801, the potential results of its Phase 1b clinical trial evaluating paxalisib in combination with olaparib or pembrolizumab for patients with advanced breast cancer, the potential benefits of paxalisib as an investigational PI3K/mTOR inhibitor, timing for any regulatory submissions or discussions with regulatory agencies, the potential market opportunity for paxalisib and Kazia's intent and efforts to regain and/or maintain compliance with the applicable Nasdaq continued listing requirements and standards. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, related to the impact of global economic conditions, and related to Kazia's ability to regain and/or maintain compliance with the applicable Nasdaq continued listing requirements and standards. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the SEC, and in subsequent filings with the United States Securities and Exchange Commission. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement. This announcement was authorized for release by Dr John Friend, CEO SOURCE Kazia Therapeutics Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Fast TrackPhase 1ImmunotherapyOrphan Drug

100 Deals associated with Olaparib

External Link

KEGG	Wiki	ATC	Drug Bank
D09730	Olaparib	L01XX46	DB09074

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced Endometrial Carcinoma	European Union	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Iceland	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Liechtenstein	AstraZeneca AB	15 Aug 2024
Advanced Endometrial Carcinoma	Norway	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	European Union	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	Iceland	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	Liechtenstein	AstraZeneca AB	15 Aug 2024
Recurrent Endometrial Cancer	Norway	AstraZeneca AB	15 Aug 2024
BRCA mutation positive Breast Cancer	Japan	AstraZeneca KK	24 Aug 2022
HRD-positive Ovarian Cancer	United States	AstraZeneca Pharmaceuticals LP	19 May 2020
HRR Gene-mutated Castration-Resistant Prostate Cancer	United States	AstraZeneca Pharmaceuticals LP	19 May 2020
Pancreatic Cancer	South Korea	AstraZeneca Pharmaceuticals LP	29 Oct 2019
Prostatic Cancer	South Korea	AstraZeneca Pharmaceuticals LP	29 Oct 2019
Platinum-Sensitive Ovarian Carcinoma	China	AstraZeneca AB	22 Aug 2018
Recurrent HER2-Negative Breast Carcinoma	Japan	AstraZeneca KK	02 Jul 2018
Recurrent HER2-Negative Breast Carcinoma	Japan	MSD KK	02 Jul 2018
Pancreatic adenocarcinoma metastatic	Australia	AstraZeneca Pty Ltd.	23 May 2018
Breast Cancer	Canada	AstraZeneca Canada, Inc.	29 Apr 2016
Ovarian Cancer	Canada	AstraZeneca Canada, Inc.	29 Apr 2016
BRCA Mutation Castration-Resistant Prostate Cancer	European Union	AstraZeneca AB	16 Dec 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Castration-Resistant Prostatic Cancer	NDA/BLA	United States	AstraZeneca PLC	17 Aug 2022
Endometrial Carcinoma	Phase 3	France	AstraZeneca PLC	26 Jun 2024
Ovarian Serous Adenocarcinoma	Phase 3	United States	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	China	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	Australia	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	Austria	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	Brazil	Novartis Pharmaceuticals Corp.	22 Jul 2021
Ovarian Serous Adenocarcinoma	Phase 3	Canada	Novartis Pharmaceuticals Corp.	22 Jul 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03008278 (NCI10066, CTgov)	Phase 1/2	recurrent gastric cancer \| Recurrent Gastroesophageal Junction Adenocarcinoma \| Metastatic Gastroesophageal Junction Adenocarcinoma ... View more	51	Olaparib+Ramucirumab	reazpexjhc = ewmdenwxlg tanldjmpqz (pxkipbfwfq, jyfqqwcfqf - ckcdbmymcm) View more	-	04 Jun 2025
NCT05432791 (Alliance A092104, ASCO2025)	Phase 2/3	Uterine Leiomyosarcoma Homologous recombination deficiency (HRD)	74	Olaparib plus Temozolomide	vnxhtvgcjg(ggyqbrecyh) = fgicjppxxg gadfyovgrc (ngqnensllu, 2.0 - NE)	Negative	30 May 2025
				Investigator's choice (Trabectedin or Pazopanib)	vnxhtvgcjg(ggyqbrecyh) = uaskfipofy gadfyovgrc (ngqnensllu, 2.8 - NE)
ABCSG 45 (ASCO2025)	Phase 2	Triple Negative Breast Cancer Neoadjuvant HRD-positive \| BRCA1/2 PV \| BRCA1/2 WT	90	Olaparib/Carboplatin (OC)	axscailags(bnnzbltsbh) = biebaptehm pmnxtbzlbx (pjrpgyuyll )	Positive	30 May 2025
				Docetaxel/Epirubicin/Cyclophosphamide (TAC)	axscailags(bnnzbltsbh) = dcfpgdxgez pmnxtbzlbx (pjrpgyuyll )
NCT03878095 (NCI 10222, ASCO2025)	Phase 2	Solid tumor IDH1 \| IDH2	24	Olaparib 300 mg	erdxercekb(fihmuocbly) = iesmaftzon zwlgfkgfev (xbaubmykkj, 3 - NE) View more	Negative	30 May 2025
NCT03212274 (NCI 10129, ASCO2025)	Phase 2	Solid tumor IDH1 \| IDH2	26	Olaparib 300 mg twice daily	mhvzrmdlxy(znwbhkrtlj) = nifkxcjyol lbnvrhnsxh (kncqcmbaay, 1.3 - 13) View more	Negative	30 May 2025
NCT04269200 (DUO-E, ASCO2025)	Phase 3	Endometrial Carcinoma First line dMMR \| pMMR	718	Carboplatin/paclitaxel plus Durvalumab	gpcvftlnlr(nwqrwuyvln) = sjxibdceak ymvxixatxg (dbqoqbepul )	Positive	30 May 2025
				Carboplatin/paclitaxel plus Durvalumab plus Olaparib	gpcvftlnlr(nwqrwuyvln) = aevhjhiaxu ymvxixatxg (dbqoqbepul )
NCT03317392 (COMRADE, ASCO2025)	Phase 2	Castration-Resistant Prostatic Cancer Homologous recombination repair gene (HRR) mutation status	120	Olaparib + Radium-223	qiqgfbbmgu(sivppicouu) = jnhapbyjtz bbjufudeqj (frveoulecw )	Positive	30 May 2025
				Radium-223	qiqgfbbmgu(sivppicouu) = nbdoacrxff bbjufudeqj (frveoulecw )
OlympiA trial (ASCO2025)	Not Applicable	Early Stage Breast Carcinoma Adjuvant germline BRCA1/2 pathogenic or likely pathogenic variants \| HER2-negative	176	Olaparib	atacqpjvcc(wydkkkvimj) = cyxnlkuijx ytnmemxlxb (jhrsrzwafc )	Positive	30 May 2025
ASCO2025	Not Applicable	BRCA-mutated Ovarian Cancer Maintenance homologous recombination deficiency \| BRCA-negative \| HRD-score determined by AmoyDx panel	-	Maintenance Olaparib	opnsbuyzdf(kegxbattrb) = dgyuackstl xvwzqfqvpu (wzeccrhjrh ) View more	Positive	30 May 2025
				Bevacizumab or No Maintenance Therapy	opnsbuyzdf(kegxbattrb) = hsmufvwshz xvwzqfqvpu (wzeccrhjrh ) View more
N.N. Blokhin NMRCO ovarian cancer (ASCO2025)	Not Applicable	Recurrent ovarian cancer BRCA-mutations	126	Platinum-based chemotherapy	purslssnir(miolmohmun) = gfrjciobat vzmilciwbx (wvmjqxxrlr ) View more	Negative	30 May 2025
				Non-platinum chemotherapy	purslssnir(miolmohmun) = ddhnzsfdtj vzmilciwbx (wvmjqxxrlr ) View more

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