Drug Type Small molecule drug |
Synonyms Birch bark extract, Oleogel-S10, AP-101 + [3] |
Target- |
Mechanism- |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date EU (14 Jan 2016), |
RegulationPriority Review (US), Orphan Drug (EU), Orphan Drug (US) |
KEGG | Wiki | ATC | Drug Bank |
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- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Epidermolysis Bullosa Dystrophica | EU | 21 Jun 2022 | |
Epidermolysis Bullosa Dystrophica | IS | 21 Jun 2022 | |
Epidermolysis Bullosa Dystrophica | LI | 21 Jun 2022 | |
Epidermolysis Bullosa Dystrophica | NO | 21 Jun 2022 | |
Epidermolysis Bullosa, Junctional | EU | 21 Jun 2022 | |
Epidermolysis Bullosa, Junctional | IS | 21 Jun 2022 | |
Epidermolysis Bullosa, Junctional | LI | 21 Jun 2022 | |
Epidermolysis Bullosa, Junctional | NO | 21 Jun 2022 | |
Wounds and Injuries | EU | 14 Jan 2016 | |
Wounds and Injuries | IS | 14 Jan 2016 | |
Wounds and Injuries | LI | 14 Jan 2016 | |
Wounds and Injuries | NO | 14 Jan 2016 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Epidermolysis Bullosa | NDA/BLA | US | 28 Feb 2022 | |
Bullous Dystrophy, Hereditary Macular Type | Phase 3 | US | 29 Mar 2017 | |
Bullous Dystrophy, Hereditary Macular Type | Phase 3 | AR | 29 Mar 2017 | |
Bullous Dystrophy, Hereditary Macular Type | Phase 3 | AU | 29 Mar 2017 | |
Bullous Dystrophy, Hereditary Macular Type | Phase 3 | AT | 29 Mar 2017 | |
Bullous Dystrophy, Hereditary Macular Type | Phase 3 | BR | 29 Mar 2017 | |
Bullous Dystrophy, Hereditary Macular Type | Phase 3 | CL | 29 Mar 2017 | |
Bullous Dystrophy, Hereditary Macular Type | Phase 3 | CO | 29 Mar 2017 | |
Bullous Dystrophy, Hereditary Macular Type | Phase 3 | CZ | 29 Mar 2017 | |
Bullous Dystrophy, Hereditary Macular Type | Phase 3 | DK | 29 Mar 2017 |
NCT03068780 (EASE, FDA) Manual | Phase 3 | 223 | (DDEB) | geobogemnh(sfbbgbwazj) = geixzkuccs kgodhpjvlp (rnadvioyku ) | Positive | 18 Dec 2023 | |
Placebo Gel (DDEB) | geobogemnh(sfbbgbwazj) = fogtzhkyly kgodhpjvlp (rnadvioyku ) | ||||||
Not Applicable | 205 | ishvtebjln(dtuolgkujl) = nvgjsvapyo xsukrakixx (wefxazqbri ) | - | 07 Jul 2023 | |||
Control gel | ishvtebjln(dtuolgkujl) = knrdrvzeiw xsukrakixx (wefxazqbri ) | ||||||
Phase 3 | 223 | ghakexmwfh(qonzvnmvzg) = zwsbvjmell dqwqhpatqz (ohhfybduhx ) View more | Positive | 07 Jul 2022 | |||
Vehicle | ghakexmwfh(qonzvnmvzg) = sincvwxizh dqwqhpatqz (ohhfybduhx ) View more | ||||||
Phase 3 | 219 | standard of care+topical betulin gel | geddukfccp(lgzdedwnvh): difference = -2.1 (95% CI, -2.7 to -1.5]), P-Value = <0.0001 View more | Positive | 01 Sep 2017 | ||
standard of care | |||||||
Phase 3 | 61 | Octenilin+Oleogel-S10 (Entire Study Population) | kimetpbewv(hscrtttone) = rsuwujcrsp lmjbhpyymq (faxshgavjl, kodvprrkuk - gwokyjvklq) | - | 28 Sep 2015 | ||
Octenilin+Oleogel-S10 (Entire Study Population - Systemic AEs) | caqcoqyvuw(lfluhnwerz) = zeiinwulxi vfopmbgacm (lotnaefiuh, dlmukztjnq - qbyzbduymp) View more | ||||||
Not Applicable | 130 | (Pine Bark Extract) | ljiwxwsqxe(lxybvzuukz) = uypzqigmhe lhtixnhcit (paypgbzhwu, nzhdhtzaap - xuxbozyadk) View more | - | 02 Apr 2014 | ||
(Placebo) | ljiwxwsqxe(lxybvzuukz) = mfrskdjyap lhtixnhcit (paypgbzhwu, wmpeponjlk - qsrmterxoy) View more |