New Drug OLC Could Revolutionize CKD Treatment, Countdown to US FDA Approval!

Shilpa Medicare, a leading integrated pharmaceutical group, today announced its CDMO partner, Unicycive Therapeutics, Inc. Has successfully had the U.S. Food and Drug Administration (USFDA) accept a New Drug Application (NDA) for lanthanum oxycarbonate (OLC). This important advance marks a major breakthrough for Unicycive in the field of treating chronic kidney disease (CKD) hyperphosphatemia. The USFDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025.

If the OLC is eventually approved by the USFDA, it will be a significant boon for dialysis treated CKD hyperphosphatemia patients. Currently, these patients face an onerous treatment regimen that often requires taking up to 12 pills a day. The introduction of OLC is expected to significantly improve the treatment burden for patients as it requires a lower pill burden in terms of the number and size of pills per dose. In addition, OLC pills are designed to swallow rather than chew, increasing patient convenience and compliance.

Chronic kidney disease (CKD) is a serious health condition characterized by a gradual loss of kidney function over time. The kidneys play a vital role in filtering waste and excess fluid from the blood, regulating blood pressure, balancing electrolytes, and producing hormones that affect red blood cell production and calcium metabolism. When kidney function declines, waste can build up in the body, leading to a range of serious health complications.

Unicycive has entered into a long-term manufacturing contract with Shilpa, ensuring that OLC will be available on a commercial scale once approved by the U.S. Food and Drug Administration. Unicycive's NDA is currently under review and is expected to commercialize and launch an OLC in the U.S. market in the second half of 2025.

Shilpa Medicare not only has a strong presence in oncology and non-oncology apis, peptides, polymers, differentiated finished dosage formulations, but also offers a wide range of formulations including oral dispersion membranes and transdermal patches. In addition, Shilpa has a well-crafted portfolio of biological products. To support its broad reach, Shilpa Medicare also provides end-to-end CDMO services to pharmaceutical companies worldwide, and its strong R&D and manufacturing capabilities are strongly supported by four R&D departments and seven manufacturing facilities.