Drugs / Azelaic acid
Azelaic acid
also known as
AzA · Finacea · BAY39-6251 · Acide azelaique · Acido azelaico · Anchoic acid · azelaic acid (azelan) · Azelate · +6 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | FINACEA | — | 2005-05-05 | fda.gov ↗ |
| Approved | US (FDA) | AZELEX | — | 1995-09-13 | fda.gov ↗ |
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05416333 | Aug 2024 → Nov 2026 expected | central centrifugal cicatricial alopecia | Wake Forest University Health Sciences | Active not recruiting | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT06966388 | Aug 2025 → Nov 2027 expected | breast cancer | Virginia Commonwealth University | Recruiting | No outcome recorded |
| Phase 1 | NCT03094403 | Jul 2016 → Mar 2017 | rosacea | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01430533 | Sep → Dec 2011 | — | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01430312 | Sep → Dec 2011 | — | LEO Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01257919 | Jan → Mar 2011 | rosacea | LEO Pharma | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT01025635 | Dec 2009 → Aug 2010 | rosacea | LEO Pharma | Completed | Met primary |
| Phase 2 | NCT00617903 | Jan → Jun 2008 | rosacea | LEO Pharma | Completed | No outcome recorded |
| Phase 35 trials · 2 met primary | ||||||
| Phase 3 | NCT03287791 | Jul 2016 → Jun 2017 | rosacea | Actavis Inc. | Completed | Met primary |
| Phase 3 | NCT02120924 | Jul 2013 → Sep 2014 | rosacea | Actavis Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01659853 | Sep → Dec 2012 | rosacea | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT01555463 | Sep 2012 → Jan 2014 | rosacea | LEO Pharma | Completed | Met primary |
| Phase 3 | NCT00031096 | Jan → Jul 2002 | acne | LEO Pharma | Completed | No outcome recorded |
| Phase 49 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT05446402 | Jun 2022 → May 2023 | acne | Northwestern University | Completed | No outcome recorded |
| Phase 4 | NCT03418610 | Dec 2017 → Jan 2019 | rosacea | Clinical Research Center of the Carolinas | Completed | No outcome recorded |
| Phase 4 | NCT02147691 | May 2014 → Jan 2015 | rosacea | Derm Research, PLLC | Completed | No outcome recorded |
| Phase 4 | NCT02058628 | Feb → Sep 2014 | acne | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT01387048 | Aug 2011 → Aug 2012 | acne | University of Magdeburg | Completed | No outcome recorded |
| Phase 4 | NCT05014906 | May 2010 → Sep 2011 | rosacea | Dermatology Specialists Research | Completed | No outcome recorded |
| Phase 4 | NCT01038869 | Dec 2009 → Apr 2010 | acne, hyperpigmentation of the skin | Derm Research, PLLC | Completed | No outcome recorded |
| Phase 4 | NCT00927771 | Jun 2009 → Jun 2010 | hyperpigmentation of the skin | Callender Center for Clinical Research | Unknown | No outcome recorded |
| Phase 4 | NCT00855595 | Feb → Apr 2009 | rosacea | LEO Pharma | Completed | Missed primary |
| Phase not applicable2 trials | ||||||
| — | NCT07327983 | May → Nov 2025 | hyperpigmentation of the skin | Gujranwala medical college District Headquarters Hospital, Gujranwala | Completed | No outcome recorded |
| — | NCT01631656 | Jul 2010 → Feb 2011 | rosacea | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT05887219 Comparator | Nov 2022 → Apr 2023 | hyperpigmentation of the skin | Combined Military Hospital Abbottabad | Completed | No outcome recorded |
| Phase 1 | NCT03689010 Comparator | Dec 2017 → Aug 2018 | rosacea | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00408330 Comparator | Dec 2006 → Mar 2007 | seborrheic dermatitis | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00403949 Comparator | Nov 2006 → Mar 2007 | acneiform dermatitis | LEO Pharma | Completed | No outcome recorded |
| Phase 2/3 | NCT03035955 Comparator | Dec 2010 → Feb 2012 | rosacea | Wake Forest University | Completed | No outcome recorded |
| Phase 3 | NCT01494467 Comparator | Dec 2011 → Aug 2013 | rosacea | Galderma R&D | Completed | Met primary |
| Phase 4 | NCT01139047 Comparator | Jun 2010 | skin disorder | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT01139008 Comparator | Jun 2010 | skin disorder | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT00417937 Comparator | Jan → Jun 2007 | rosacea | LEO Pharma | Completed | No outcome recorded |
| — | NCT01850095 Comparator | Mar 2012 → Jun 2013 | acne | Marco Alexandre Dias da Rocha | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2019-03-18 | Perrigo Company | Regulatory Perrigo Announces Tentative FDA Approval For The Generic Version Of Finacea® Foam, 15% perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) a leading global provider of "Quality, Affordable, Self-Care Products™" today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Finacea ® Foam (azelaic acid) 15%. |
| 2018-11-20 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Azelaic Acid Gel, 15% glenmarkpharma.com ↗
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Azelaic Acid Gel, 15% , a generic version of Finacea®1 Gel, 15%, of Leo Pharma A/S. |
| 2018-02-20 | Perrigo Company | Regulatory Perrigo Confirms Patent Challenge For Generic Version Of Finacea® Foam, 15% perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) today announced that it has filed a Paragraph IV Abbreviated New Drug Application with the U.S. Food and Drug Administration for a generic version of Finacea ® Foam (azelaic acid foam, 15%). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-04-02 | Perrigo Company | Perrigo Announces Patent Litigation Settlement For The Generic Version Of Finacea® Foam, 15% perrigo.com ↗ |
| 2019-03-18 | Perrigo Company | Perrigo Announces Tentative FDA Approval For The Generic Version Of Finacea® Foam, 15% perrigo.com ↗ |
| 2018-11-20 | Glenmark Pharmaceuticals Ltd. India | Glenmark Pharmaceuticals receives ANDA approval for Azelaic Acid Gel, 15% glenmarkpharma.com ↗ |
| 2018-02-20 | Perrigo Company | Perrigo Confirms Patent Challenge For Generic Version Of Finacea® Foam, 15% perrigo.com ↗ |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Azelaic Acid | “Skinoren 15% gel (azelaic acid) is an alternative treatment affecting several pathogenetic factors of acne” NCT01387048 ↗34“Brightening Day Cream - SPF 15 (5% Azelaic Acid, 2% Hyaluronic Acid, 1%Niacinamide)” NCT05446402 ↗ “Azelaic Acid” NCT03094403 ↗ |
| Known as | Acide azelaique | ChEMBL registry synonym — accepted as the source's own label CHEMBL1238 ↗ |
| Known as | Acido azelaico | ChEMBL registry synonym — accepted as the source's own label CHEMBL1238 ↗ |
| Known as | Anchoic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL1238 ↗ |
| Known as | AzA | “Azelaic acid (AzA; HOOC-(CH2)7-COOH) is a naturally occurring compound that interferes with acne pathogenesis by virtue of its antikeratinizing, antibacterial, and...” NCT01387048 ↗4“two common topical agents for the treatment of rosacea--azelaic acid gel (AzA) 15% and metronidazole gel 1%--used in conjunction with anti-inflammatory dose doxycycline (40 mg...” PMID 20645521 ↗ Jun 2010 “A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face” NCT00408330 ↗ “Azelaic acid (AzA) is approved for the treatment of rosacea in a 15% gel formulation.” PMID 26244354 ↗ Jul 2015 “Azelaic Acid (AzA) 15% in Topical Treatment” NCT00403949 ↗ |
| Known as | azelaic acid (azelan) | “azelaic acid (azelan)” NCT01850095 ↗ |
| Known as | Azelate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1238 ↗ |
| Known as | Azelex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1238 ↗ |
| Known as | BAY39-6251 | “Azelaic acid foam, 15% (BAY39-6251)” NCT01555463 ↗3“Azelaic acid foam, 15% (BAY39-6251)” NCT00617903 ↗ “Azelaic acid foam, 15% (BAY39-6251)” NCT01025635 ↗ “Azelaic acid (Finacea, BAY39-6251)” NCT00855595 ↗ |
| Known as | Finacea | “Marketed by Intendis, Finacea® (azelaic acid) Gel, 15% is a safe and effective topical therapy used for the treatment of moderate facial rosacea.” NCT02120924 ↗4“Finacea® (azelaic acid) Foam, 15% contains azelaic acid, a naturally occurring saturated dicarboxylic acid” NCT03287791 ↗ “Azelaic acid (Finacea, BAY39-6251)” NCT00855595 ↗ “Finacea® (azelaic acid) Gel, 15%” NCT03094403 ↗ “Finacea® (Azelaic acid Foam) 15%” NCT03689010 ↗ |
| Known as | Lepargylic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL1238 ↗ |
| Known as | NSC-19493 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1238 ↗ |
| Known as | SH H 655 BA | “Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.” NCT00031096 ↗ |
| Known as | Skinoren | “Skinoren 15% gel (azelaic acid) is an alternative treatment affecting several pathogenetic factors of acne” NCT01387048 ↗ |
| Known as | ZK 62498 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1238 ↗ |
| Modality | Small molecule | “a naturally occurring saturated dicarboxylic acid” NCT02120924 ↗ |
| Route | Topical | “applied topically two times per day.” NCT00031096 ↗ |