amylase

Biologicalapproved

Approved

Dec 9, 1996

An amylase is an enzyme that catalyses the hydrolysis of starch into sugars. Amylase is present in the saliva of humans and some other mammals, where it begins the chemical process of digestion. Foods that contain large amounts of starch but little sugar, such as rice and potatoes, may acquire a slightly sweet taste as they are chewed because amylase degrades some of their starch into sugar. The pancreas and salivary gland make amylase to hydrolyse dietary starch into disaccharides and trisaccharides which are converted by other enzymes to glucose to supply the body with energy. Plants and some bacteria also produce amylase. Specific amylase proteins are designated by different Greek letters. All amylases are glycoside hydrolases and act on α-1,4-glycosidic bonds. — Wikipedia

Clinical trial activity

1 trials · 1 clinical orgs · 7 marketing orgs

Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
0

Earliest trial started Sep 30, 2010 (NCT01267565)

Timeline

1990s

  1. Dec 9, 1996

    Organon — Earliest FDA Approval

  2. Dec 9, 1996

    Organon — NDA Organization

2000s

  1. Apr 30, 2009

    AbbVie — NDA Secondary Org

  2. Aug 27, 2009

    Eurand Pharmaceuticals — Marketing Organization

  3. Aug 27, 2009

    Forest Laboratories — NDA Secondary Org

  4. Aug 27, 2009

    Eurand Pharmaceuticals — NDA Secondary Org

2010s

  1. Apr 12, 2010

    Vivus — NDA Secondary Org

  2. Mar 1, 2012

    Allergan PLC (2015) — Marketing Organization

  3. Mar 1, 2012

    Allergan PLC (2015) — NDA Secondary Org

  4. May 17, 2012

    Digestive Care, Inc. — NDA Secondary Org

Indications

Mechanism of action

Combination products

Approval history

  • approvedDec 9, 1996

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • amylase
  • amylase

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT01267565N/ASep 30, 2010University of Bordeaux
Showing 1 of 1 trials
Page 1 / 1

Organizations

Research & Development (1)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of BordeauxAcademic/Hospital1112010
1 organizations
Page 1 / 1

Marketing (10)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Apr 30, 2009
Allergan PLC (2015)For profitMKTGMar 1, 2012
Allergan PLC (2015)For profitNDA2Mar 1, 2012
Digestive Care, Inc.For profitNDA2May 17, 2012
Eurand PharmaceuticalsFor profitMKTGAug 27, 2009
Eurand PharmaceuticalsFor profitNDA2Aug 27, 2009
Eurand PharmaceuticalsFor profitMKTGAug 27, 2009
Forest LaboratoriesFor profitNDA2Aug 27, 2009
OrganonFor profitNDADec 9, 1996
VivusFor profitNDA2Apr 12, 2010