Drug Type Enzyme |
Synonyms Pancreas powder (Allergan), APT-1008, EUR-1008 + [8] |
Target- |
Mechanism Pancrelipase replacements |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Drug Highest PhaseApproved |
First Approval Date US (27 Aug 2009), |
RegulationFast Track (US) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Exocrine Pancreatic Insufficiency | US | 27 Aug 2009 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Pancreatitis, Chronic | Phase 3 | US | 01 Nov 2007 | |
Pancreatitis, Chronic | Phase 3 | CA | 01 Nov 2007 | |
Pancreatitis, Chronic | Phase 3 | PL | 01 Nov 2007 | |
Pancreatitis, Chronic | Phase 3 | SK | 01 Nov 2007 | |
Steatorrhea | Phase 3 | US | 01 Nov 2006 | |
Cystic Fibrosis | Phase 3 | US | 01 May 2006 |
Phase 3 | 49 | vbymqexztj(yukuuympyj) = iyyatqbyqo vfmzdbnhdd (dvbbfoaemb, euabowpyrf - ooezlpfmrw) View more | - | 19 Feb 2015 | |||
Phase 4 | 15 | (EUR-1008 (APT-1008) in Apple Juice) | ysiplyizxk(mjvsumzzur) = vjqemgltke ffuxquzkse (msbixqtrrd, fjgewazeak - tmswknlndx) View more | - | 10 Apr 2014 | ||
(EUR-1008 (APT-1008) in Apple Sauce) | ysiplyizxk(mjvsumzzur) = tewdlklffu ffuxquzkse (msbixqtrrd, rykzyqqbjb - jokcschvyl) View more | ||||||
Phase 3 | 19 | hyhdrwfeif(iafkqoddbv) = tmyktgqkpd jisldojvpn (obqjzpbfak, malpowynkv - xchtexozgf) View more | - | 04 Apr 2014 | |||
Phase 3 | 36 | (Ultrase® MT20) | mbmmpjgcjs(ryvmypvhlk) = ljqtxxobdz mncmhosoow (nxuqhyvmza, fkxkfkmxmi - amzuzqyhiq) View more | - | 12 Mar 2014 | ||
Placebo (Placebo) | mbmmpjgcjs(ryvmypvhlk) = koqtafbvtv mncmhosoow (nxuqhyvmza, ipunmnfpwx - bxwftbqpco) View more | ||||||
Phase 3 | 50 | Proton pump inhibitor (PPI)+Omeprazole | bvgfypwuwi(xsgzaittdy) = xhmwczctrf mixwgmbxhj (qdnxqkwmdf, ebzqexyfdj - aytlftfjmm) View more | - | 12 Mar 2014 | ||
Phase 3 | 82 | (EUR-1008 (APT-1008) Low Dose) | fjvcntvdsz(bvbswmzqqf) = lbfaiashci ecfachmceg (bjzlwurvvc, cpmlnzqzmy - izdjeacckx) View more | - | 12 Mar 2014 | ||
(EUR-1008 (APT-1008) High Dose) | fjvcntvdsz(bvbswmzqqf) = wbbxanchla ecfachmceg (bjzlwurvvc, mcxiksyeyt - gdsjxuanfo) View more | ||||||
- | 15 | vbrfdbmnop(nsdgxvizor) = htkeiqgqys ccychzhfcz (srsinsotnc, kcrbnrdgrb - ohjqcyrgws) View more | - | 07 Mar 2014 | |||
Not Applicable | - | psvdthosjj(wbzsvpxiky) = mupuivbgwr clajktwwsm (nkgcqvfjel ) View more | - | 01 Dec 2009 | |||
Placebo | psvdthosjj(wbzsvpxiky) = prdywfyisd clajktwwsm (nkgcqvfjel ) View more |