Table 1.
Oral Insulin Delivery Systems Undergoing Clinical Trials
Product name | Company | Technology | Status | Reference |
Capsulin | Diabetology (Jersey, UK) | AxcessTM; enteric-coated capsule filled with a mixture of insulin, an absorption enhancer, and a solubilizer | Phase IIa in T1DM and phase II in T2DM completed; agreement with USV Limited (Mumbai India) to complete the development and commercialize for the Indian market | 21 |
ORMD-0801 | ([a-z]+)Oramed (Jerusalem, Israel) | Enteric-coated capsule containing insulin and adjuvants to protect the protein and promote its intestinal uptake | Phase IIa in T1DM and phase IIb in T2DM | 22 |
ORA2 | BOWS Pharmaceuticals AG (Zug, Switzerland) | Capsule containing insulin in dextran matrix | Phase II in T2DM; agreement with Orin Pharmaceuticals AG (Stockholm, Sweden) for the development | 23 |
— | Emisphere Technologies (Cedar Knolls, NJ) | Eligen®; capsule containing insulin and an absorption enhancer that facilitates the passive transcellular transport | Phase II in T2DM suspended | 24 |
NN1952 | Novo Nordisk (Bagsvaerd, Denmark) | GIPET® from Merrion Pharmaceuticals (Dublin, Ireland); capsule or tablet containing absorption enhancers that activate micelle formation, facilitating transport of insulin | Cancelled after phase II | 25,26 |
NN1953; NN1954 | Novo Nordisk (Bagsvaerd, Denmark) | Tablet of long-acting insulin analog | Phase I in T1DM and T2DM | 25 |
IN-105 | Biocon (Bangalore, India) | Insulin modified with a small PEG | Phase II; searching for other company to pursue development | 27 |
HDV-I | Diasome (Conshohocken, PA) | Liposomal insulin, which is hepatic-directed vesicles–insulin, HDV-I, in orally administered forms | Phase III | 28,29 |
— | Biolaxy (Shanghai, China) | NOD Technology; insulin-loaded bioadhesive nanoparticles | Phase I | 30 |
— | Access Pharmaceuticals (Dallas, TX) | CobaCyteTM; nanoparticle or polymer containing insulin, coated with vitamin B12 for targeted delivery | Phase I | 31 |