Filling a syringe

CP016 Long Acting Growth Hormone

CP016 is a long acting injection of somatropin (recombinant human growth hormone) that uses Critcal Pharmaceuticals’ proprietary CriticalMix™ drug delivery technology. It is being developed as a once every two week injection and has completed preclinical development.

Patients suffering from growth hormone deficiency are currently treated with a once-daily injection of somatropin, which has a considerable impact upon patients' lives. By reducing the number of injections required with CP016 compared to current medicines, we expect to improve the therapeutic outcome by increasing efficacy through improving patient compliance and reducing the side effect profile.

Human growth hormone deficiency in children results in stunted growth and delayed muscle development and in adults in diminished lean body mass, poor bone density as well as a number of other physical and psychiatric symptoms. In addition to treating growth hormone deficiencies, somatropin is used to treat people with Turners syndrome and HARS, a syndrome associate with HIV infection, as well as certain other muscle wasting diseases due to its role in fat metabolism and muscle development. The market for somatropin products is currently estimated to be $3.1 billion annually. 

CriticalMix Technology

CriticalMix rig

CriticalMix enables the manufacture of highly active sustained release depot products for bimonthly, monthly or less frequent injection.

Read more

CP024 Nasal hGH

measuring height

CP024 has completed two Phase 1 clinical trials where our intranasal growth hormone has shown comparable activity to injection.

Read more

Prof Steve Howdle, Critical Pharmaceuticals
“We found absolutely no effect of our supercritical process on hGH structure, and the formulated drug was then shown to be 100% active. The data we have collected will be essential to convince the regulatory agencies that our process is safe, and we are now confident in progressing our lead product through pre-clinical testing.”