Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Evra | — | 2002-08-22 | europa.eu ↗ |
| Approved | US (FDA) | ORTHO EVRA | — | 2001-11-20 | fda.gov ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04423068 | Dec 2020 → Apr 2022 | pregnancy disorder | Children's Mercy Hospital Kansas City | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT04017195 | Jul → Dec 2019 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01535820 | Mar → Jul 2011 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT00258063 | May → Sep 2004 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT00258076 | Apr → Sep 2004 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT00254865 | Aug 2002 → Mar 2003 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07365904 | Dec 2025 → Nov 2026 expected | — | Mylan Pharmaceuticals Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT07083635 | Jul 2025 → Sep 2026 overdue | hemometra, menstrual disorder | Chulalongkorn University | Recruiting | No outcome recorded |
| Phase 2 | NCT06048536 | Dec 2023 → Jan 2024 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05139121 | Oct 2021 → Jan 2025 | — | Viatris Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00236769 | Nov 1997 → Oct 1999 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00236782 | Oct 1997 → Mar 1999 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00236795 | Jan 1997 → Mar 1999 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT02367833 | Jan 2015 → Dec 2017 | bone disorder | Penn State University | Completed | No outcome recorded |
| Phase 4 | NCT00261482 | Jul 2003 → Dec 2004 | — | Janssen Pharmaceutica N.V., Belgium | Completed | No outcome recorded |
| Phase 4 | NCT00653016 | Oct 2002 → Aug 2003 | — | Janssen-Ortho Inc., Canada | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT00439972 Comparator | Feb 2007 → Dec 2011 | — | University of Washington | Unknown | No outcome recorded |
| Phase 3 | NCT00984789 Comparator | May 2009 → Sep 2010 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00185354 Comparator | Nov 2004 → Apr 2006 | — | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT01044056 Comparator | Mar → Jun 2004 | — | Organon and Co | Completed | No outcome recorded |
| — | NCT01087879 Comparator | Oct 2007 → Jan 2011 | — | University of Oulu | Completed | No outcome recorded |
| — | NCT00554632 Comparator | Apr 2003 → Aug 2005 | venous thromboembolism | University of Vermont | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-07-29 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Regulatory Viatris Receives U.S. FDA Approval for Gwyn Lo™, a Once-Weekly Contraceptive Patch viatris.com ↗
Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved Gwyn Lo™ (norelgestromin and ethinyl estradiol transdermal system). |
| 2025-12-18 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Regulatory Viatris Provides Pipeline Update on Four Regulatory Milestones viatris.com ↗
The U.S. FDA has accepted for review the New Drug Application (NDA) for the Company's investigational low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol) for contraception. |
| 2025-05-08 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Results Viatris Announces Positive Results from Phase 3 Study of Investigational XULANE LO™ Low Dose Patch for Birth Control in Women of Childbearing Potential viatris.com ↗
In this study, XULANE LO demonstrated a favorable efficacy and safety profile with no new safety concerns identified as well as a potential best-in-class patch performance profile. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-29 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Receives U.S. FDA Approval for Gwyn Lo™, a Once-Weekly Contraceptive Patch viatris.com ↗ |
| 2025-12-18 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Provides Pipeline Update on Four Regulatory Milestones viatris.com ↗ |
| 2025-05-08 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Announces Positive Results from Phase 3 Study of Investigational XULANE LO™ Low Dose Patch for Birth Control in Women of Childbearing Potential viatris.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Norelgestromin | “ORTHO EVRA is a combination transdermal (through the skin) contraceptive patch containing 6.00 mg of the progestin norelgestromin (NGMN) and 0.75 mg of the estrogen, ethinyl...” NCT01535820 ↗21“Participants in the TDC group will apply a 20 cm2 patch (Xulane: 20µg/d EE,150µg/d norelgestromin) to the abdomen, upper arm or buttock.” NCT02367833 ↗ “0.9 mg Ethinylestradiol/1.9 mg Gestodene) vs. a Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin)” NCT00185354 ↗ “MR-130A-01 transdermal patch, containing 2.43 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.” NCT06048536 ↗ “Ortho-Evra® contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch.” NCT00439972 ↗ “exposure to the hormones norelgestromin, norgestrel, and ethinyl estradiol in the bloodstream” NCT00258076 ↗ “MR-100A-01 is a TDS of norelgestromin 4.86 mg/ethinyl estradiol 0.264 mg.” NCT05139121 ↗ “Norelgestromin/Ethinyl estradiol transdermal patch (Ortho Evra)” NCT04423068 ↗ “norelgestromin [NGMN] and ethinyl estradiol [EE]” NCT04017195 ↗ |
| Known as | NGMN | “ORTHO EVRA® is a combination, monophasic transdermal contraceptive patch containing 6 mg of norelgestromin (NGMN) and 0.75 mg of ethinyl estradiol (EE), and delivering to the...” NCT00254865 ↗4“OBJECTIVE(S): To investigate the bleeding pattern and cycle control parameters of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD)...” PMID 25453582 ↗ Oct 2014 “ORTHO EVRA is a combination transdermal (through the skin) contraceptive patch containing 6.00 mg of the progestin norelgestromin (NGMN) and 0.75 mg of the estrogen, ethinyl...” NCT01535820 ↗ “MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)” NCT07365904 ↗ “norelgestromin [NGMN] and ethinyl estradiol [EE]” NCT04017195 ↗ |
| Route | Other | “Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin)” NCT00185354 ↗ |