The U.S. FDA greenlit China-based Triastek’s IND Application for its 3D printed drug product, T20, for cardiovascular and clotting disorders.
The U.S. Food and Drug Administration greenlit China-based Triastek, Inc.'s Investigational New Drug Application for its 3D printed drug product, T20, for cardiovascular and clotting disorders.
The Nanjing-based company noted that T20 will offer a once-daily dosing option for an undisclosed commercial medication currently taken twice per day. Triastek said T20 is designed to provide a formulation that “addresses unmet patient needs by improving adherence and therefore the opportunity for improved patient outcomes.”
T20 is being developed with Triastek’s 3D printing formulation by design method, which begins with a desired extended-release PK profile. It also uses a predictable in vivo gastrointestinal tract (GIT) dissolution-time/location profile. This profile has been predicted using what Triastek called a “physiologically-based biopharmaceutical model (PBBM) of GIT absorption to inform formulation development.” Its approach overcomes the limitations of traditional extended-release products and Triastek said its proof-of-concept has already been demonstrated in animal studies.
With its 3D technology, Triastek said it is capable of developing novel formulations that are “challenging to achieve with conventional dosage form technology to address unmet clinical needs and improve drug therapy outcomes.” Its 3D technology for drug development will initially focus on small molecule drugs.
Semping Cheng, founder and chief executive officer of Triastek noted that 3D printing technology is revolutionizing the pharmaceutical industry. T20 marks the second Triastek product to be greenlit by the FDA for clinical studies. Cheng said the IND clearance for T20 “demonstrates the significant progress in 3D printing pharmaceuticals.”
Currently, there is only one 3D printed drug approved by the FDA, Aprecia Pharmaceuticals’ Spritam, which is used in the treatment of partial-onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy. Spritam has remained the lone FDA-approved 3D printed drug since it was first greenlit in 2015.
In addition to Triastek, other companies are hoping to join Aprecia with an approved 3D-printed drug. Last month, Laxxon Medical secured financing to support its 3D screen printing technology. The company’s technology is designed to control the release of multiple active pharmaceutical ingredients within a single tablet.
Some 3D-printed medical devices have been approved by the FDA, including orthopedic implants.
There is a growing global market for both 3D printed drugs, devices and implants. In March, it was predicted that the market for 3D-printed medical implants was expected to be more than $9 billion by 2030. As of 2021, the market size for implants was less than $2 billion.
