Follow RSS for latest reports on this topicBIOD-531 - Market Research and Reports

Biodel's concentrated insulin BIOD-531 contains 400 units per milliliter (U-400) of recombinant human insulin formulated with EDTA, citrate and magnesium sulfate. Based on its unique combination of ultra-rapid absorption with a basal duration profile, BIOD-531 may provide superior meal-time glucose control for patients using Humulin® R, U-500. For patients using premixed prandial/basal insulins, BIOD-531 could enable patients to minimize injection volume while benefitting from the ultra-rapid onset of action.

The current unmet medical need for a concentrated ultra-rapid-acting insulin formulation exists among a subset of type 2 diabetes patients who demonstrate severe insulin resistance and require greater than 200 units of insulin daily to meet their insulin needs. Currently Eli Lilly's Humulin® R U-500 is the only concentrated RHI product on the U.S. market. Humulin® R U-500 concentrated insulin has a suboptimal pharmacokinetic and pharmacodynamic profile with a more delayed onset than U-100 regular human insulin or rapid-acting insulin analog formulations.

Eli Lilly and Novo Nordisk market preparations of human insulin or rapid-acting analog prandial insulins premixed with intermediate-acting basal neutral protamine insulins in a variety of ratios such as 70/30, 75/25 and 50/50. Premixes provide basal and bolus therapy with fewer injections per day. Premixes represent approximately thirty percent of the more than $8 billion global rapid-acting prandial insulin market.


BIOD-531’s ultra-rapid onset, basal duration profile, and high concentration offer improved prandial coverage while maintaining basal
coverage in insulin-resistant patients who require large doses of insulin and patients who use premixed formulations. It is hoped insulin-resistant patients will gain superior meal-time glucose control than with Humulin R, and premixed users will see improved prandial control with smaller injection volumes.

In diabetic swine, BIOD-531 demonstrated a faster rate of absorption and onset of action than Humulin R and Humalog, and a comparable duration of action to Humulin R. A U.S. phase I study has now begun and will compare pharmacokinetic, pharmacodynamic and injection site toleration profiles of BIOD-531 with Humulin R and Humalog (75/25 premixed), with data expected in first quarter of 2014.

Adapted from - Thomson Reuters Cortellis Competitive Intelligence

BioPortfolio's Easy Ordering System

  1. Search for the report you need from our store
  2. Make online payment with our easy checkout process
  3. Receive PDF report via email

Easy Online Payment or Pro Forma Invoice

We accept the following credit cards...

or can supply a pro-forma invoice if required.

We Stock...