Table 1.
List of Clinically Tested Oral Insulin Formulations.
| Company | Name | Product | Action | Development phase | Clinical trials | References# |
|---|---|---|---|---|---|---|
| Access Pharmaceuticals, Inc | CobOral™ Insulin | Coated insulin-loaded nanoparticles | Short | Preclinical | accesspharma.com | |
| Aphios Corporation | APH-0907 | Nanoencapsulated insulin/biodegradable polymer nanospheres | Short | Preclinical | aphios.com | |
| Biocon/Bristol-Myers Squibb | IN-105 | Conjugated insulin | Short | II | NCT01035801 CTRI/2008/091/000276 CTRI/2009/091/000479 CTRI/2009/091/001008 | biocon.com, clinicaltrials.gov, ctri.nic.in, Khedkar et al7 |
| Diabetology Ltd | Capsulin™ OAD | Insulin with delivery system Axcess™ | Short | II | diabetology.co.uk, Luzio et al11 | |
| Diasome Pharmaceuticals, Inc | HDV-Insulin | Hepatic-directed vesicle-insulin (nanocarrier) | Short | III | NCT00521378 NCT00814294 | diasome.com, clinicaltrials.gov |
| Emisphere Technologies, Inc | Eligen® Insulin | Insulin with chemical delivery agents (Eligen®) | Short | I | NCT00982254 | emisphere.com, clinicaltrials.gov, Kapitza et al13 |
| Jordanian Pharmaceutical Manufacturing Co PLC | JPM Oral Insulin | Liquid delivery system with insulin chitosan nanoparticles | I | jpm.com.jo, Badwan et al16 | ||
| Novo Nordisk A/S | NN1952 | Insulin analog with oral delivery system GIPET® | Short | NCT01028404 | novonordisk.com, novonordisk-trials.com, clinicaltrials.gov | |
| OI338GT (NN1953) | Insulin analog with oral delivery system GIPET® | Long | I |
NCT01334034 NCT01931137 NCT01796366 |
||
| OI362GT (NN1954) | Insulin analog with oral delivery system GIPET® | Long | I | NCT01597713 | ||
| OI287GT (NN1956) | Insulin analog with oral delivery system GIPET® | Long | I | NCT01809184 | ||
| Oramed, Inc | ORMD-0801 | Insulin with protein oral delivery system POD™ | Short | II | CTRI/2009/091/000371 NCT00867594 NCT01889667 |
oramed.com, clinicaltrials.gov, ctri.nic.in, Eldor et al,17 Eldor et al19 |
| Oshadi Drug Administration Ltd | Oshadi Icp | Insulin, proinsulin, and C-peptide in Oshadi carrier | Short | II | NCT01120912 NCT01973920 NCT01772251 | clinicaltrials.gov |
| NOD Pharmaceuticals, Inc/Shanghai Biolaxy, Inc | Nodlin | Insulin with bioadhesive nanoencapsulation (NOD Tech) | Intermediate | II | ChiCTR-TRC-12001872 | chictr.org, Li et al20 |
| Tamarisk Technologies/Deliv-RX | Insulin with serum-specific nanoencapsulation (SSNe) | deliv-rx.com | ||||
| Transgene Biotek Ltd | TBL1002OI | Proprietary nanotechnology Trabi-Oral™ | Short | Preclinical | transgenebiotek.com |
Companies performing clinical development of oral insulin formulations were identified either through publications as compiled by systematic literature search in PubMed (gray rows) or by way of press releases and/or information on company websites or clinical trial registries in case no published data were available (white rows). #, websites accessed in December 2013.