Drugs / ingenol mebutate
ingenol mebutate
also known as
PEP005 · Picato · AGN 204332 · Generic Ingenol Mebutate · IMB · Mebutate d'ingenol · Mebutato de ingenol · Picato 500
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed actinic keratosis 1 milestone | |||||
| Filed | US (FDA) | — | actinic keratosis | 2016-06-13 | “announced that it has filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) for ingenol mebutate gel (0.015% and 0.05%)” perrigo.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | PICATO | — | 2015-11-19 | fda.gov ↗ |
| Approved | EU (EMA) | Picato | — | 2012-11-15 | europa.eu ↗ |
| Approved | US (FDA) | PICATO | — | 2012-01-23 | fda.gov ↗ |
Trials 47
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03336372 | Dec 2017 → Sep 2018 | molluscum contagiosum | Center for Clinical Studies, Texas | Withdrawn | No outcome recorded |
| Phase 0 | NCT01735942 | Oct 2012 → May 2016 | actinic keratosis | Northwestern University | Withdrawn | No outcome recorded |
| Phase 112 trials | ||||||
| Phase 1 | NCT02748902 | Apr 2016 → Jan 2017 | common wart | Neal D. Bhatia, MD | Completed | No outcome recorded |
| Phase 1 | NCT02411851 | Mar 2015 → Jun 2016 | actinic keratosis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 1 | NCT02124239 | Apr → Nov 2014 | actinic keratosis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01892137 | Jul 2013 → Mar 2014 | actinic keratosis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01836367 | Mar → Aug 2013 | actinic keratosis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 1 | NCT01387711 | Aug 2011 → Jun 2012 | actinic keratosis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01302925 | Feb → Mar 2011 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 1 | NCT00850811 | Feb → Apr 2009 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 1 | NCT00850681 | Feb → Apr 2009 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 1 | NCT00659893 | Apr → Nov 2008 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 1 | NCT00544258 | Oct 2007 → May 2008 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 1 | NCT00357916 | Jun → Oct 2006 | — | Peplin | Completed | No outcome recorded |
| Phase 1/24 trials · 1 met primary | ||||||
| Phase 1/2 | NCT03452566 | Feb 2020 → Sep 2021 | actinic cheilitis | Brazilian National Cancer Institute | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03569345 | Nov 2017 → May 2018 | skin basal cell carcinoma | Merete Haedersdal | Completed | No outcome recorded |
| Phase 1/2 | NCT01820260 | Apr 2013 → Aug 2014 | actinic keratosis | LEO Pharma | Completed | Met primary |
| Phase 1/2 | NCT01803477 | Feb → Oct 2013 | actinic keratosis | LEO Pharma | Completed | No outcome recorded |
| Phase 217 trials · 1 missed | ||||||
| Phase 2 | NCT03546166 | Jul 2018 → Mar 2021 | carcinoma | Centre Hospitalier Universitaire de Nice | Completed | No outcome recorded |
| Phase 2 | NCT02723721 | Jun 2016 → Jan 2020 | lentigo maligna melanoma | Centre Hospitalier Universitaire de Nice | Completed | No outcome recorded |
| Phase 2 | NCT02377999 | Feb → Nov 2015 | anogenital human papillomavirus infection | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT02354391 | Jan 2015 → Dec 2019 | actinic keratosis | Pacific Dermaesthetics | Unknown | No outcome recorded |
| Phase 2 | NCT01998984 | Jan → Jul 2014 | actinic keratosis | LEO Pharma | Completed | Missed primary |
| Phase 2 | NCT01325688 | Apr 2011 → Mar 2012 | superficial multifocal basal cell carcinoma | Peplin | Completed | No outcome recorded |
| Phase 2 | NCT01214564 | Oct → Dec 2010 | seborrheic keratosis | Peplin | Completed | No outcome recorded |
| Phase 2 | NCT01214577 | Oct 2010 → Jan 2011 | — | Peplin | Completed | No outcome recorded |
| Phase 2 | NCT00852137 | Mar → Jun 2009 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 2 | NCT00700063 | Jun → Oct 2008 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 2 | NCT00544297 | Oct 2007 → Jan 2008 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 2 | NCT00427050 | Jan → Nov 2007 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 2 | NCT00375739 | Sep 2006 → Jun 2007 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 2 | NCT00329121 | May → Dec 2006 | skin squamous cell carcinoma | Peplin | Completed | No outcome recorded |
| Phase 2 | NCT00239135 | Sep → Dec 2005 | keratosis | Peplin | Completed | No outcome recorded |
| Phase 2 | NCT00108134 | Mar 2005 → Mar 2006 | skin basal cell carcinoma | Peplin | Completed | No outcome recorded |
| Phase 2 | NCT00108121 | Mar 2005 → May 2006 | basal cell carcinoma | Peplin | Completed | No outcome recorded |
| Phase 37 trials · 3 met primary | ||||||
| Phase 3 | NCT02473848 | Jun 2015 → Dec 2017 | actinic keratosis | Günther Hofbauer | Terminated | No outcome recorded |
| Phase 3 | NCT02459795 | May → Dec 2015 | actinic keratosis | Padagis LLC | Completed | No outcome recorded |
| Phase 3 | NCT02361216 | Apr 2015 → Mar 2016 | actinic keratosis | LEO Pharma | Completed | Met primary |
| Phase 3 | NCT02385318 | Feb → Dec 2015 | actinic keratosis | Padagis LLC | Completed | No outcome recorded |
| Phase 3 | NCT00916006 | Jun → Sep 2009 | actinic keratosis | Peplin | Completed | Met primary |
| Phase 3 | NCT00917306 | Jun → Sep 2009 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 3 | NCT00915551 | Jun → Sep 2009 | actinic keratosis | Peplin | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT02866695 | Oct 2016 → Jul 2018 | actinic keratosis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT02446223 | Jan 2015 → Sep 2016 | actinic keratosis | Goldman, Butterwick, Fitzpatrick and Groff | Completed | No outcome recorded |
| Phase 4 | NCT01926496 | Sep 2013 → Jul 2019 | actinic keratosis | LEO Pharma | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03508856 | Nov 2015 → Aug 2016 | actinic keratosis | Skin Laser & Surgery Specialists | Completed | No outcome recorded |
| — | NCT02242747 | May → Jul 2014 | actinic keratosis | University of Sao Paulo | Completed | No outcome recorded |
| Comparator or background therapy16 trials | ||||||
| Phase 1 | NCT01449513 Comparator | Sep 2011 → May 2012 | actinic keratosis | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT00546611 Comparator | Oct 2007 → ? | common wart | Peplin | Withdrawn | No outcome recorded |
| Phase 2 | NCT00432185 Comparator | Feb 2007 → Mar 2010 | skin basal cell carcinoma | Peplin | Completed | No outcome recorded |
| Phase 2 | NCT00107965 Comparator | Mar → Sep 2005 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 3 | NCT03200912 Comparator | Aug 2016 → Mar 2017 | actinic keratosis | Actavis Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02654769 Comparator | Feb → Sep 2015 | actinic keratosis | Actavis Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01787383 Comparator | Feb 2013 → Jan 2014 | actinic keratosis | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01600014 Comparator | May 2012 → Feb 2014 | actinic keratosis | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01541553 Comparator | Mar 2012 → Jul 2013 | actinic keratosis | LEO Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00942604 Comparator | Jul → Oct 2009 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 3 | NCT00742391 Comparator | Sep 2008 → Feb 2009 | actinic keratosis | Peplin | Completed | No outcome recorded |
| Phase 4 | NCT02990221 Comparator | Apr 2017 → Apr 2018 | actinic keratosis | University of Campania Luigi Vanvitelli | Completed | No outcome recorded |
| Phase 4 | NCT02716714 Comparator | Apr 2015 → Jun 2016 | actinic keratosis | Korea University | Completed | No outcome recorded |
| Phase 4 | NCT02406014 Comparator | Apr 2015 → Jun 2016 | actinic keratosis | LEO Pharma | Completed | No outcome recorded |
| Phase 4 | NCT02281682 Comparator | Nov 2014 → Jul 2018 | actinic keratosis | Maastricht University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02251652 Comparator | Apr 2013 → Dec 2014 | actinic keratosis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2017-11-02 | Perrigo Company | Regulatory Perrigo Announces Tentative FDA Approval for a First-to-File Generic Version of Picato® Gel 0.05% perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for the generic version of Picato ® Gel (ingenol mebutate) 0.05%. |
| 2017-10-24 | Perrigo Company | Regulatory Perrigo Announces Tentative FDA Approval For A First-To-File Generic Version Of Picato® Gel .015% perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for the generic version of Picato ® Gel (ingenol mebutate) 0.015%. |
| 2016-06-13 | Perrigo Company | Regulatory Perrigo Confirms First To File Patent Challenge For Generic Version Of Picato® Gel (0.015% And 0.05%) perrigo.com ↗
Perrigo Company plc (NYSE: PRGO; TASE) announced that it has filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) for ingenol mebutate gel (0.015% and 0.05%), the generic versions of Picato® gel (0.015% and 0.05%). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-09-28 | Perrigo Company | Perrigo Announces Patent Litigation Settlement for the Generic Version of Picato® Gel perrigo.com ↗ |
| 2017-11-02 | Perrigo Company | Perrigo Announces Tentative FDA Approval for a First-to-File Generic Version of Picato® Gel 0.05% perrigo.com ↗ |
| 2017-10-24 | Perrigo Company | Perrigo Announces Tentative FDA Approval For A First-To-File Generic Version Of Picato® Gel .015% perrigo.com ↗ |
| 2016-06-13 | Perrigo Company | Perrigo Confirms First To File Patent Challenge For Generic Version Of Picato® Gel (0.015% And 0.05%) perrigo.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 69 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ingenol mebutate | “Picato® is a topical gel for cutaneous application that contains the active substance ingenol mebutate, which is obtained from the aerial parts of the plant species Euphorbia peplus.” NCT02723721 ↗48“We investigated the efficacy and safety of a new topical field therapy for actinic keratosis, ingenol mebutate gel (0.015% for face and scalp and 0.05% for trunk and extremities).” PMID 22417254 ↗ Mar 2012 “The rapid and strong clinical efficacy of the first-in-class, ingenol mebutate, against actinic keratosis (AK) has resulted in its recent approval.” PMID 27612149 ↗ Sep 2016 “PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate 0.05% and 0.015% Gel Followed by Hand Washing in Healthy Subjects.” NCT01302925 ↗ “PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: results of a randomized phase IIa trial.” PMID 20546215 ↗ May 2010 “We investigated the efficacy and safety of field treatment of AKs with ingenol mebutate gel following cryosurgery.” PMID 24918567 ↗ Jun 2014 “Topical Therapy with Ingenol Mebutate Gel 0.015% for Actinic Keratosis on an Expanded Area of the Chest.” PMID 28979661 ↗ Aug 2017 “Tolerability and Pharmacokinetics of Ingenol Mebutate 0.05% Gel” PMID 25584134 ↗ Dec 2014 “ingenol mebutate gel 0.01% versus vehicle on normal skin.” PMID 24765228 ↗ Apr 2014 “Picato® (a registered and marketed ingenol mebutate gel)” NCT01803477 ↗ “PEP005 (ingenol mebutate) Gel, 0.05%” NCT01325688 ↗ |
| Known as | AGN 204332 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1863513 ↗ |
| Known as | Generic Ingenol Mebutate | “Drug: Generic Ingenol Mebutate” NCT03200912 ↗ |
| Known as | IMB | “ingenol mebutate gel (IMB) is a new topical field therapy.” NCT02242747 ↗ |
| Known as | Mebutate d'ingenol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1863513 ↗ |
| Known as | Mebutato de ingenol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1863513 ↗ |
| Known as | PEP005 | “Ingenol mebutate, in a gel formulation referred to as PEP005 (ingenol mebutate) Gel or PEP005 Gel, has been evaluated in clinical trials as field therapy for the topical...” NCT02411851 ↗25“This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and...” NCT01214564 ↗ “PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: results of a randomized phase IIa trial.” PMID 20546215 ↗ May 2010 “Assess the efficacy and safety of ingenol mebutate (formerly PEP005) gel at 3 dosing regimens for the treatment of actinic keratosis.” PMID 19467365 ↗ Jun 2009 “PEP005 (Ingenol Mebutate) gel, 0.015%” NCT00915551 ↗ “PEP005 (ingenol mebutate) Gel, 0.05%” NCT00852137 ↗ “PEP005 (Ingenol mebutat Gel, 0.05 %)” NCT01387711 ↗ “PEP005 (ingenol mebutate) Gel, 0.01%” NCT00850681 ↗ “PEP005 (ingenol mebutate) Gel” NCT00850811 ↗ “PEP005 (ingenol mebutate) Gel” NCT00742391 ↗ “PEP005 (ingenol mebutate) Gel” NCT01214577 ↗ |
| Known as | Picato | “Picato® is a topical gel for cutaneous application that contains the active substance ingenol mebutate, which is obtained from the aerial parts of the plant species Euphorbia peplus.” NCT02723721 ↗5“Full treatment course with Ingenol mebutate (Picato®) 0.015% topical gel, apply day 2,3 and 4” NCT02354391 ↗ “Ingenol Mebutate (Picato®) 0.015% gel” NCT03508856 ↗ “Drug: Ingenol Mebutate (Picato®)” NCT03200912 ↗ |
| Known as | Picato 500 | “Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma” NCT03546166 ↗ |
| Action | Activate | “ingenol mebutate is able to kill melanoma cells mainly by induction of apoptosis which seems to be secondary to the activation of Protein Kinase C.” NCT02723721 ↗ |
| Modality | Small molecule | “Ingenol mebutate is the active agent (a macrocyclic diterpene ester) in the sap of the plant Euphorbia peplus.” PMID 23553119 ↗ Jun 2013 |
| Route | Topical | “0.0025% PEP005 Topical Gel (Day 1,2 application)” NCT00107965 ↗ |