Drugs / Acthar
Acthar
also known as
ACTHAR Gel · H.P. Acthar Gel · Corticotropin · Repository Corticotropin Injection · RCI · repository corticotropin · ACTH · Acthar Injectable Product · +4 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | CORTICOTROPIN | — | 1980-12-01 | fda.gov ↗ |
| Approved | US (FDA) | ACTHAR | — | 1950-07-03 | fda.gov ↗ |
Trials 44
1949195019511952195319541955195619571958195919601961196219631964196519661967196819691970197119721973197419751976197719781979198019811982198319841985198619871988198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027202820292030
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01987167 | Nov 2013 → Dec 2016 | optic neuritis | Neuro-Ophthalmologic Associates, PC | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07833163 | Sep 2026 → Sep 2027 expected | Behcet disease | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT01984268 | Jun 2014 → Sep 2016 | rheumatoid arthritis | Dartmouth-Hitchcock Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT01813591 | Apr 2013 → Dec 2014 | migraine disorder | Dent Neuroscience Research Center | Completed | No outcome recorded |
| Phase 2 | NCT00004758 | Nov 1993 → ? | infantile spasms | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03068754 | Jun 2017 → Nov 2019 | amyotrophic lateral sclerosis | Mallinckrodt | Terminated | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02683889 | Feb 2019 → Jun 2024 | focal segmental glomerulosclerosis | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 3 | NCT03511625 | Oct 2018 → Feb 2020 | rheumatoid arthritis | Attune Health Research, Inc. | Unknown | No outcome recorded |
| Phase 3 | NCT02282930 | Mar 2015 → Jun 2018 | IgA glomerulonephritis, proteinuria | Mayo Clinic | Completed | No outcome recorded |
| Phase 428 trials · 1 met primary · 4 missed | ||||||
| Phase 4 | NCT07346079 | Dec 2025 → Aug 2027 expected | gout | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT02523092 | Nov 2022 → Jan 2025 | sarcoidosis | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 4 | NCT02399462 | Mar → Jul 2021 | focal segmental glomerulosclerosis | University of North Carolina, Chapel Hill | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT04169061 | Nov 2019 → Nov 2020 | keratitis | Mallinckrodt | Completed | No outcome recorded |
| Phase 4 | NCT02920710 | Feb 2019 → Nov 2020 | sarcoidosis | The Cleveland Clinic | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03656692 | Oct 2018 → Jul 2020 | intermediate uveitis, panuveitis, posterior uveitis | Mallinckrodt | Terminated | No outcome recorded |
| Phase 4 | NCT03419650 | Jul 2018 → Aug 2021 | psoriatic arthritis | IRIS Research and Development, LLC | Completed | No outcome recorded |
| Phase 4 | NCT03287635 | Jul 2018 → Feb 2020 | dry eye syndrome | Toyos Clinic | Completed | No outcome recorded |
| Phase 4 | NCT03408405 | Jun 2018 → Jan 2021 | steroid-resistant nephrotic syndrome | Rhode Island Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03025828 | Mar 2018 → Dec 2020 | membranous glomerulonephritis | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT03320070 | Feb 2018 → Nov 2021 | pulmonary sarcoidosis | Mallinckrodt | Completed | Missed primary |
| Phase 4 | NCT03126760 | May 2017 → Jul 2020 | relapsing-remitting multiple sclerosis | Mallinckrodt | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03021317 | Dec 2016 → Oct 2020 | multiple sclerosis | University of Chicago | Terminated | No outcome recorded |
| Phase 4 | NCT02953821 | Dec 2016 → Jul 2019 | systemic lupus erythematosus | Mallinckrodt | Completed | Missed primary |
| Phase 4 | NCT02633046 | Oct 2016 → Aug 2020 | primary focal segmental glomerulosclerosis | Mallinckrodt | Completed | No outcome recorded |
| Phase 4 | NCT02779153 | Oct 2016 → May 2019 | systemic lupus erythematosus | NYU Langone Health | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02546492 | Aug 2016 → May 2021 | chronic transplant rejection | University of Maryland, Baltimore | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02769702 | Jun 2016 → Jan 2017 | anterior uveitis | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 4 | NCT02298491 | May 2016 → Nov 2020 | neurosarcoidosis | University of Maryland, Baltimore | Completed | Missed primary |
| Phase 4 | NCT02245841 | Jun 2015 → Jul 2021 | juvenile dermatomyositis | The Cleveland Clinic | Completed | Met primary |
| Phase 4 | NCT02382523 | Feb 2015 → Jan 2019 | IgA glomerulonephritis, proteinuria | Baylor College of Medicine | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02057523 | Sep 2014 → Mar 2015 | disease related to solid organ transplantation, proteinuria | University of Illinois at Chicago | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01939132 | Jul 2013 → Jul 2014 | psoriatic arthritis | Fiechtner, Justus J., M.D., P.C. | Unknown | No outcome recorded |
| Phase 4 | NCT01838174 | May 2013 → Jan 2022 | multiple sclerosis | University of Colorado, Denver | Terminated | Missed primary |
| Phase 4 | NCT01888354 | Apr 2013 → Aug 2014 | multiple sclerosis | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 4 | NCT01753401 | Jan 2013 → Oct 2015 | systemic lupus erythematosus | Mallinckrodt | Completed | No outcome recorded |
| Phase 4 | NCT01769937 | Oct 2012 → Apr 2013 | systemic lupus erythematosus | Fiechtner, Justus J., M.D., P.C. | Completed | No outcome recorded |
| Phase 4 | NCT00854750 | May 2009 → May 2010 | multiple sclerosis | Elliot Frohman | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable7 trials | ||||||
| — | NCT02725177 | Jul 2016 → Dec 2021 | anterior uveitis, panuveitis | The Cleveland Clinic | Completed | No outcome recorded |
| — | NCT02258217 | Jun 2014 → Jun 2016 | relapsing-remitting multiple sclerosis | OhioHealth | Completed | Mixed |
| — | NCT02434757 | Feb 2014 → Oct 2015 | rheumatoid arthritis | Ronald J. Rapoport, MD | Unknown | No outcome recorded |
| — | NCT02006849 | Jan 2014 → Jan 2019 | kidney disorder | Wake Forest University Health Sciences | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT01906684 | Aug 2013 → Jan 2014 | multiple sclerosis | Tanner Foundation for Multiple Sclerosis | Unknown | No outcome recorded |
| — | NCT01900093 | Jul 2013 → Mar 2018 | multiple sclerosis | Aaron Miller | Unknown | No outcome recorded |
| — | NCT00005890 | Mar 1996 → ? | infectious disease with sepsis | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT02486744 Comparator | Mar 2015 → Jul 2016 | end stage renal failure | Youngstown State University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00805753 Comparator | Jan 2009 → Sep 2013 | idiopathic membranous glomerulonephritis | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT00986960 Comparator | Dec 2009 → Sep 2010 | multiple sclerosis | University at Buffalo | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT06964269 Comparator | Feb 2025 → Feb 2028 expected | autoimmune disease, dry eye syndrome, neurotrophic keratopathy | Toyos Clinic | Recruiting | No outcome recorded |
| Phase 4 | NCT05546047 Comparator | Mar 2019 → Oct 2023 | immunotactoid or fibrillary glomerulopathy | NephroNet, Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT04080076 Comparator | Jan 2019 → Sep 2024 | kidney disorder | NephroNet, Inc. | Withdrawn | No outcome recorded |
| Phase 4 | NCT02541955 Comparator | Jul 2017 → May 2025 | rheumatoid arthritis | Veena Ranganath, MD, MS | Completed | No outcome recorded |
| Phase 4 | NCT03082573 Comparator | Mar 2017 → Feb 2018 | rheumatoid arthritis | Iraj Sabahi Research Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT02188017 Comparator | Jun 2014 → Dec 2016 | pulmonary sarcoidosis | University of Cincinnati | Unknown | No outcome recorded |
| Phase 4 | NCT01948388 Comparator | Sep 2013 → Sep 2016 | rheumatoid arthritis | Gaylis, Norman B., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT01926054 Comparator | Jul 2013 → Feb 2018 | lupus nephritis | Ohio State University | Withdrawn | No outcome recorded Stop: Enrollment |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-13 | Mallinckrodt | Keenova Announces Publication of New Acthar® Gel (repository corticotropin injection) Manuscript in the Journal of Comparative Effectiveness Research gcs-web.com ↗ |
| 2026-07-13 | Endo USA Inc., a Keenova Therapeutics Company | Keenova Announces Publication of New Acthar® Gel (repository corticotropin injection) Manuscript in the Journal of Comparative Effectiveness Research mediaroom.com ↗ |
| 2020-08-07 | Upsher-Smith Laboratories | Upsher-Smith and AmbioPharm Announce Partnership Agreement to Develop and Market Corticotropin Injection upsher-smith.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ACTHAR | “We propose to study the use of purified porcine Acthar Gel (ACTHAR, Mallinckrodt Pharmaceuticals) for treatment of steroid resistance nephrotic syndrome (SRNS) in a prospective...” NCT03408405 ↗25“ACTHAR is a 39-amino acid peptide natural form of adrenocorticotropin hormone (ACTH) that was initially approved in 1952 by the FDA.” NCT02725177 ↗ “Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6 months” NCT02282930 ↗ “H.P. Acthar Gel (repository corticotropin injection)” NCT01888354 ↗ |
| Known as | ACTH | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02282930 ↗ |
| Known as | ACTHAR Gel | “We propose that neuro-ophthalmologic hallmarks of MS, INO (an ocular motor syndrome) and optic neuritis (a visual sensory syndrome), can be studied with objective methods...” NCT00854750 ↗20“INTRODUCTION: There is a substantial unmet need for effective therapies to treat patients with refractory dry eye disease (DED). The goal of this open-label pilot study was to...” PMID 35460497 ↗ Apr 2022 “The goal of this study was to evaluate the efficacy and safety of repository corticotropin injection (RCI, Acthar® Gel) in patients with pulmonary sarcoidosis and to validate...” PMID 37072607 ↗ Apr 2023 “Repository corticotrophin injection (RCI, Acthar Gel) and intravenous methylprednisolone (IVMP) improve the rate but not the extent of visual recovery following acute optic neuritis.” PMID 37261907 ↗ Jun 2023 “course of ACTHar Gel alone at 80 units per week or in combination with oral Tacrolimus at 1 mg BID” NCT04080076 ↗ “In this cohort Acthar gel will be administered to the enrolled patient with chrnic AMR.” NCT02546492 ↗ “Acthar Gel” NCT04169061 ↗ |
| Known as | Acthar Injectable Product | “Drug: Acthar Injectable Product” NCT03511625 ↗ |
| Known as | adrenocorticotrophin | “ACTH or adrenocorticotrophin is a hormone produced by the pituitary gland (a gland at the base of your brain) that is involved in stimulating your adrenal glands to secrete a...” NCT00805753 ↗ |
| Known as | corticotrophin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01948388 ↗ |
| Known as | Corticotropin | “15 days of intramuscular (IM) or sub-cutaneous corticotropin (SQ) Acthar (ACTH).” NCT01838174 ↗ |
| Known as | H.P. Acthar Gel | “H.P. Acthar Gel (repository corticotropin injection).” NCT01906684 ↗9“H.P. Acthar Gel (repository corticotropin injection)” NCT01888354 ↗ “Drug: H.P. Acthar Gel” NCT01813591 ↗ “H.P. Acthar Gel” NCT01753401 ↗ |
| Known as | Purified Cortrophin Gel | “The treatment period is double-blind, and the patients will be randomized to treatment with 40 U Purified Cortrophin® Gel or 80 U Purified Cortrophin® Gel in a 1:1 ratio.” NCT07346079 ↗ |
| Known as | RCI | “INTRODUCTION: There is a substantial unmet need for effective therapies to treat patients with refractory dry eye disease (DED). The goal of this open-label pilot study was to...” PMID 35460497 ↗ Apr 20222“The goal of this study was to evaluate the efficacy and safety of repository corticotropin injection (RCI, Acthar® Gel) in patients with pulmonary sarcoidosis and to validate...” PMID 37072607 ↗ Apr 2023 “Repository corticotrophin injection (RCI, Acthar Gel) and intravenous methylprednisolone (IVMP) improve the rate but not the extent of visual recovery following acute optic neuritis.” PMID 37261907 ↗ Jun 2023 |
| Known as | repository corticotropin | “H.P. Acthar Gel (repository corticotropin) Injection, 80 U daily for 10 days, then 80 U twice weekly for up to a total of 24 weeks on therapy.” NCT02725177 ↗ |
| Known as | Repository Corticotropin Injection | “INTRODUCTION: There is a substantial unmet need for effective therapies to treat patients with refractory dry eye disease (DED). The goal of this open-label pilot study was to...” PMID 35460497 ↗ Apr 20223“H.P. Acthar Gel (Repository Corticotropin Injection)” NCT01939132 ↗ “Repository Corticotropin Injection” NCT01753401 ↗ |
| Known as | Trade name: Acthar Gel | “Trade name: Acthar® Gel” NCT03068754 ↗ |
| Action | Activate | “RCI has adrenal-stimulating and melanocortin receptor-stimulating properties” PMID 37261907 ↗ Jun 2023 |
| Modality | Peptide | “ACTHAR is a 39-amino acid peptide natural form of adrenocorticotropin hormone (ACTH)” NCT02725177 ↗ |
| Route | Intravenous | “corticotropin 1-24 IV” NCT00005890 ↗ |