Disease state overview

SH-105 is well established for the treatment of cancer in adults, as evidenced by ongoing use across multiple indications:

  • Breast cancer​ (approximately 339,250 patients in the US diagnosed per year)1
  • Ovarian cancer (approximately 19,880 patients in the US diagnosed per year)1
  • Bladder cancer (approximately 81,880 patients in the US diagnosed per year)1

Regulatory Status

Shorla Oncology have completed a successful pre-IND meeting with the US Health Authority, the Food and Drug Administration (‘FDA’) on our oncology drug SH-105. The FDA’s prompt and definitive response confirms our clinical and regulatory strategy and aligns with our plan to accelerate the filing of our New Drug Application (‘NDA’). This positive outcome strengthens our efforts to bring SH-105 to market benefiting women suffering from breast and ovarian cancer. A significant milestone on Shorla Pharma’s journey of bringing innovative oncology products to market.

1 American Cancer Society. Cancer Facts & Figures, 2021.