PARP2 inhibitors are a class of drugs that target the enzyme Poly (ADP-ribose) polymerase 2 (PARP2), which plays a significant role in DNA repair. These inhibitors have garnered considerable attention in cancer treatment, particularly in cancers with deficiencies in DNA repair pathways, such as BRCA-mutated breast and ovarian cancers. The mechanism of action involves blocking PARP2 activity, leading to the accumulation of DNA damage and the inability of cancer cells to repair their DNA properly. This eventually results in cancer cell death. Besides their application in cancer therapy, PARP2 inhibitors have shown potential in other diseases, including neurodegenerative disorders like Alzheimer's and Parkinson's. In these conditions, modulating PARP2 activity may help preserve neuronal health and function. However, while PARP2 inhibitors are promising targeted therapies, more research is needed to optimize their use, determine their long-term effects, and identify the best patient populations to benefit from these treatments. As ongoing studies unravel the potential of PARP2 inhibitors, these drugs remain a promising avenue for advancing precision medicine in various debilitating diseases. Companies are trying to find new and novel molecules to prevent and cure these diseases. The development and launch of more unique products by the market players will significantly enhance the revenue of the PARP2 Inhibitors market over the forecast years. For instance, according to the World Cancer Research Fund International, in 2020, ovarian cancer is the 8TH most common cancer in women globally, with more than 313,000 new cases. Also, according to the American Cancer Society, in 2023, it is estimated that about 19,710 women will receive a new diagnosis of ovarian cancer.
Several of these inhibitors are on the market, while many are in ongoing clinical trials. Companies in their pipelines have products in various stages of clinical trials. 2 products are in Phase 4, 6 products are in Phase 3, and 6 products are in Phase 2 of the clinical trials.
Key Developments of PARP2 Inhibitors
- In June 2023, Talzenna (talazoparib) was approved by the FDA in combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC).
- In June 2023, Lynparza (Olaparib) with Abiraterone and Prednisone or Prednisolone was approved by the FDA for the treatment of adult patients with BRCA-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) for whom chemotherapy is not clinically indicated.
- In April 2023, European Union (EU) approved Johnson & Johnson’s Akeega for the treatment of adult patients with BRCA-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- In December 2022, Lynparza (Olaparib) with Abiraterone and Prednisone or Prednisolone was approved by the European Union (EU) for the treatment of adult patients with BRCA-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC).
- In April 2020, Zejula (niraparib) was approved by the FDA as the only once daily dose1st line monotherapy maintenance treatment for women with Platinum-Responsive Advanced Ovarian Cancer regardless of biomarker indication.
Approved molecules
- Lynparza (olaparib)
- Zejula (niraparib)
Drugs in Pipeline
- Talzenna (talazoparib)
- veliparib (ABT-888)
- AiRuiYi (fluzoparib)
- Rubraca (rucaparib)
- Partruvix (pamiparib)
- senaparib (IMP4297)
- stenoparib (2X-121)
- SC10914
- venadaparib (NOV 1401)
- nesuparib (JPI-547)
- TQB3823
- ABT-767
- AMXI-5001
- Akeega (abiraterone/niraparib)
- HTMC0435
- HWH340
- RP12146
- TSL-1502
- simmiparib (SMOCL-9112)
Clinical Activity and Developments of PARP2 Inhibitors
As of July 2023, 19 products for 345 diseases are in clinical trials. For instance,
- In December 2023, completed a Phase 4 trial to evaluate the real-time tolerability of Niraparib in maintenance after Platinum-based chemotherapy for patients with Ovarian Cancer late relapse.
- In March 2022, AstraZeneca completed a Phase 4 trial to study the efficacy and safety of Olaparib maintenance monotherapy in Platinum sensitive relapsed Non gBRCAm Ovarian cancer patients.
- In October 2021, AstraZeneca completed a Phase 3 trial to study the clinical effectiveness and safety of Olaparib maintenance monotherapy in Metastatic Breast Cancer patients.
|
Molecule name |
Number of studies |
|
Lynparza (Olaparib) |
414 |
|
Zejula (Nilaparib) |
198 |
|
Rubraca (Rucaparib) |
67 |
|
AiRioYui (Fluzoparib) |
69 |
|
Talzenna (Talazoparib) |
111 |
Target Indication Analysis of PARP2 Inhibitors
PARP2 inhibitors primarily find extensive use in cancer therapy, particularly in cancers with deficiencies in DNA repair pathways. Their prominent application is seen in breast and ovarian cancers with BRCA mutations, where PARP2 inhibitors exploit synthetic lethality – inhibiting PARP2 further impairs the DNA repair process in cancer cells already compromised by BRCA mutations, leading to their selective death. These inhibitors have shown promising results in clinical trials and have been approved for the treatment of certain BRCA-mutated cancers. Beyond cancer, PARP2 inhibitors have emerged as potential therapeutic agents in neurodegenerative diseases like Alzheimer's and Parkinson's, as these enzymes play a role in DNA repair in neurons. The inhibition of PARP2 may offer neuroprotective effects, providing a novel approach in combating these debilitating conditions. Nevertheless, ongoing research continues to explore other possible indications, as well as optimize the use and potential combination strategies of PARP2 inhibitors to expand their clinical impact.
PARP2 Inhibitors Market
The global net sales of Lynparza by AstraZeneca were $2.6 billion in the financial year 2022, which was 12% more than the sales in 2021, and Merck and Co. generated a revenue of $1116 million in the financial year 2022, which was 13% more than the last year. In the USA, Lynparza generated a sales revenue of $1,226 million in the financial year 2022. The global net sales of Zejula (niraparib) were $578.19 million in the financial year 2022. The sales of the drugs are driven by an increasing prevalence of indicated diseases. USA and Europe’s favorable reimbursement policies make the drugs available to their people at an affordable price. Along with this, good insurance coverage is given by the government, that act as the growth driver for the market.
Latin America
Europe
Asia Pacific
Middle East
North America
Frequently Asked Questions
Lynparza (olaparib), Zejula (niraparib) and Talzenna (Talazoparib) are approved by the FDA while Rubraca (rucaparib) has received accelerated approval from the FDA.
These are being used in various indications like Ovarian cancer, Prostate cancer, Breast cancer and others.
Merck (MSD), AstraZeneca, GSK plc., J&J and Pfizer are some of the major market players for PARP2 Inhibitors.
Rising incidence of diseases improvement in technologies, development of new treatment lines in the market and changing lifestyles leading to different type of cancers like Breast cancer, Glioblastoma and Urogenital neoplasms are the key opportunities for PARP2 Inhibitors in the market.
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- Merck (MSD)
- AstraZeneca (USA)
- GSK plc. (UK)
- J&J (USA)
- Takeda Pharmaceuticals (Japan)
- Pfizer (USA)
- AbbVie (USA)
- Clovis Oncology (USA)
- Jiangsu Hengrui Pharmaceuticals Co., Ltd. (China)
- EMD Serono (USA)
- BeiGene, Inc. (Switzerland)
- IMPACT Therapeutics (China)
- Allarity Therapeutics Inc. (USA)
- Oncoheroes Bioscences Inc (USA)
- Jiangxi Qingfeng Pharmaceutical Co Ltd (China)
- Shanghai De Novo Pharmatech (China)
- National OncoVenture (South Korea)
- Ildong Pharmaceutical Co Ltd (South Korea)
- Roche (Switzerland)
- Jeil Pharmaceutical Co Ltd (South Korea)
- Sino Biopharmaceutical Ltd. (Hong Kong)
- AtlasMedx, Inc. (USA)
- Shanghai Huilun Pharmaceutical Group Co., Ltd. (China)
- WuXi AppTec (China)
- Hubei Biocause Pharmaceutical Co., Ltd. (China)
- Incozen Therapeutics Pvt. Ltd. (India)
- Rhizen Pharmaceuticals AG (Switzerland)
- Tasly Pharmaceuticals, Ltd. (USA)
- Shanghai Acebright Pharma (China)