CDSCO Panel Grants Go Ahead for Levim Lifetech's Phase I/III Teriparatide Trial
New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended grant of permission to Levim Lifetech Private Limited to conduct a Phase I/III clinical trial of Teriparatide Injection IP 600 mcg/2.4 mL (250 mcg/mL), a recombinant DNA (rDNA) origin product, as per the revised protocol submitted by the firm.
The recommendation was made in light of the earlier SEC (Endocrinology & Metabolism) observation dated 09 October 2025, after which the company submitted a revised clinical trial protocol for the biosimilar Teriparatide product.
The proposed study is titled “A Prospective, Randomized, Assessor-blinded, Multicentric, Parallel Group Phase-I/III Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Biosimilar Teriparatide of Levim Lifetech Pvt. Ltd. with Reference Product (Forteo® of Eli Lilly) in Subjects with Osteoporosis at High Risk of Fracture”, under protocol number ICS/LEV/2025-006, Version 2.0 dated 27 October 2025.
Teriparatide is a recombinant parathyroid hormone (PTH) analog and a potent osteoanabolic agent. It is made up of the first amino(N)-terminal 34 amino acids of the human PTH. First approved in the United States in November 2002 and in Europe in April 2003, teriparatide makes the first approved drug in a new category of osteoporosis therapy called anabolic therapy. Teriparatide is used in the treatment of osteoporosis in men and women.
Parathyroid hormone (PTH) is an endogenous hormone that regulates calcium and phosphate metabolism in bone and kidney. It regulates bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. It mediates its physiological actions by binding to the PTH receptors. Excess PTH - such as in certain disease states like hyperparathyroidism - can cause increased osteoclast activity and accelerated bone resorption. Interestingly, the effects of PTH depend on the dose and pattern of exposure of PTH to the bone. Continuous exposure to PTH promotes bone resorption, whereas intermittent exposure to low-dose PTH can induce bone formation more favourably than bone resorption.
Similarly, teriparatide's skeletal effects depend upon the systemic exposure pattern. Once-daily administration of teriparatide stimulates new bone formation on trabecular and cortical (periosteal and/or endosteal) bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. Teriparatide mediates its osteoanabolic actions by binding to the N-terminal moiety to PTH type 1 receptors (PTH type 1R), which are G-protein coupled receptors expressed on various cells, including osteoblasts, osteocytes, and renal tubular cells.
Binding of teriparatide to PTH receptors on osteoblasts activates the downstream PKA- and PKC-dependent signaling pathways that promotes anabolic effects on bone.For example, teriparatide increases expression of pro-osteoclastogenic cytokines like receptor activator of nuclear factor kappa-B ligand (RANKL) and macrophage colony-stimulating factor. It also upregulates transcriptional expression of pro-osteoblastogenic growth factors like insulin-like growth factor 1 (IGF1) and fibroblast growth factor 2 (FGF2). Teriparatide also downregulates the synthesis of sclerostin, which is a negative regulator of bone formation. It also promotes the differentiation of osteoblasts.
After detailed deliberation, the committee recommended for the grant of permission to conduct the Phase I/III clinical trial as per the protocol presented by the firm.
