Calcitriol Poised for FDA Approval as Vitamin D to Treat Hypocalcemia

Calcitriol Poised for FDA Approval as Vitamin D to Treat Hypocalcemia

CalcitriolThe biopharmaceutical company Rockwell Medical is anxiously awaiting approval from the FDA for its injectable Vitamin D drug, Calcitriol CAS# 32222-06-3. This promising new indication approval was submitted in April of 2013, with the goal of better managing hypocalcemia in patients who experience chronic renal dialysis. As an active injectable treatment known as the brand name Calcijex, the patent for this efficacious drug expires on August 2, 2019. Calcitriol has been shown to effectively and safely reduce elevated parathyroid hormone levels, which is unfortunately a common problem amongst patients on recurrent renal dialysis. Patients who experience this reduction of their parathyroid hormone levels not only display an ample betterment in renal osteodystrophy, they also encounter a vivifying intestinal calcium transport. Additionally, the administration of Calcitriol via a bolus injection lends itself to an accelerated bioavailability in the bloodstream.

On May 29, 2013 another exciting announcement was revealed by researchers at Rockwell Medical when they divulged that pertinent data from their CRUISE-1 study involving Calcitriol will be available in July 2013. The CRUISE-1 trial is the initial part of this clinical study focusing on Rockwell’s latest drug candidate- Soluble Ferric Pyrophosphate, or SFP. As a medication used to aid patients on dialysis who suffer from iron deficiency, SFP is effectual at transferring iron to the bone marrow of these patients. The delivery of Soluble Ferric Pyrophosphate is non-invasive, and is executed through the intravenous solution. The addition of a fast acting Calcitriol injection for patients who are experiencing hypocalcemia and hyperparathyroidism to the treatment plan makes the protocol for patients who are on chronic dialysis easier, tolerable and more comfortable.

LGM Pharma provides Calcitriol for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.


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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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