Sebela Pharmaceuticals’ development strategy aims to advance the company’s mission of improving patients’ lives with innovative pharmaceuticals. To achieve this, the development team works closely with the commercial team to navigate marketplace realities in order to deliver differentiated medicines that matter to patients and physicians. Investments in clinical programs are prioritized towards opportunities that possess a validated target, areas of medical need, and a known regulatory pathway with the FDA.
The company’s pipeline has been transformed from its legacy focus on innovative colonoscopy preparations, towards novel indications in Gastroenterology. Sebela’s expanded development strategy seeks to build upon the company’s leadership in Gastroenterology, while fueling long-term growth through building a pipeline of differentiated products that are important to patients.
Sebela Women’s Health, in recognition of the significant need for hormone-free, long-acting, reversible contraception, has made significant investments in hormone-free IUD development. Sebela’s lead product candidate, a Copper 175 mm2 IUD, is in late-stage Phase 3 clinical development. Sebela recognizes the importance of contraceptive choice and is also developing a hormonal IUD offering with 52 mg Levonorgestrel. The hormonal IUD shares important technological features with the hormone-free IUD, while maintaining the potential to offer meaningful differentiation from existing products for women and their HCPs.1,2
Copper 175 mm2 IUD is in Phase 3 clinical research. It is limited by United States Federal Law to investigational use.1
52 mg Levonorgestrel IUD is Phase 3 ready. It is limited by United States Federal Law to investigational use.2
Over the past 5 years, Sebela’s R&D teams have successfully completed 14 clinical trials and have submitted 3 NDA applications. In their careers, our team members have conducted over 200 clinical studies and submitted dozens of NDA applications. Most recently highlighting this capability, SUTAB® received FDA approval in November 2020 and SUFLAVE™ received FDA approval in June 2023.
References
1. Clinical Trials.gov. Evaluation of the Efficacy, Safety and Tolerability of VeraCept IUD. Updated August 24, 2023. Accessed December 9, 2024. https://clinicaltrials.gov/ct2/show/NCT03633799
2. ClinicalTrials.gov. Evaluation of the Efficacy, Safety, and Tolerability of LevoCept. Updated March 5, 2024. Accessed December 9, 2024. https://clinicaltrials.gov/ct2/show/NCT04457076