1) API—Can be a small molecule, peptide, or protein. 2) Carrier (with Albumin Avidity)—Either soluble or insoluble, tailored to stability and release profile. 3) Reversible prodrug linker—Aromatic Cyclic Imide, DKP Carbamate, Bicin, AEG (2-((2-aminoethyl)amino)acetic acid), Pyroglutamate 4) Functional agents—antiadsorbents, buffering agents, isotonicity modifiers, preservatives, antimicrobials, stabilizers, diffusion enhancers, and oxidation protectants. 5) Excipients—mannitol, metacresol, sodium hydroxide, succinic acid, water for injection, diluents, adjuvants, and vehicles optimized based on the API’s physicochemical properties.

Yorvipath 294 micrograms/0.98ml solution for injection prefilled pen (2 pen pack) costs 9272.97 USD

In a 52-week efficacy and safety clinical study of TransCon PTH, 72 out of 78 patients (92%) experienced at least one Grade 1 treatment-emergent adverse event (TEAE) by the 52nd week. Additionally, eight patients experienced a serious adverse event (SAE). Treatment-related TEAEs reported in participants included injection site reactions (26%), hypercalcemia (14%), nausea (9%), headache (8%), and hypocalcemia (5%). Two out of 8 SAEs were attributed to hypocalcemia.

Not provided

Not provided

Not provided

Novo Nordisk oversees the commercial manufacturing, clinical development, regulatory approval, and market distribution of products within the TransCon Metabolic Disorders pipeline.

Not provided

Not provided

Not provided

No proprietary excipient used

No novel excipient or existing excipient used

No residual solvent used

No delivery device

• Biodegradable
• Room temperature storage
• At least 1 year shelf life

The unmodified API, encapsulated within the TransCon carrier, is gradually released from the microsphere environment into the surrounding tissues by deconjugating from the linker. This controlled release facilitates the distribution of the API and subsequent activation of target receptors. Additionally, the inactive carrier is dissociated and subsequently eliminated from the system. This mechanism results in pharmacokinetic properties comparable to those observed with daily dosing regimens.

TransCon formulations (pre-filled pen) can be administered via intravenous, subcutaneous, or intratumoral routes. These formulations can be injected using a standard injection kit equipped with a 21–25 gauge needle as a ready-to-use liquid formulation with a pen injector, depending on the designated route of administration and the molecular integrity of the formulation.

TransCon prefilled pens remain stable for at least one year when stored at cold temperatures.

Do not freeze. Store away from heat. Keep TransCon Formulation in the packaging to protect it from light. Until first use, store the formulation in the refrigerator between 2°C to 8°C. After first use, store it for 14 days at room temperature below 30°C (86°F). After each use, remove the needle and put the pen cap on to protect from light. Discard the prefilled pen 14 days after first use.