Drugs / Mitotane
Mitotane
also known as
CB 313 · Chloditan · Chlodithane · Lysodren · Mitotan · Mitotane (Lysodren) · Mitotano · NSC-38721 · +4 more
Small molecule targets CYP11A1, CYP11B1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Lysodren | — | 2004-04-28 | europa.eu ↗ |
| Approved | US (FDA) | LYSODREN | — | 1970-07-08 | fda.gov ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02057237 | Sep 2013 → Apr 2015 | prostate cancer | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT06831175 | Mar 2025 → Dec 2026 expected | adrenal cortex carcinoma | West China Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05634577 | Mar 2023 → Jul 2024 | adrenal cortex carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02788201 | Mar 2017 → Oct 2019 | urinary bladder cancer, urothelial carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00778817 | Dec 2008 → May 2012 | adrenal cortex carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT00001339 | Aug 1993 → Aug 2002 | adrenal cortex carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 33 trials · 1 missed | ||||||
| Phase 3 | NCT03583710 | Aug 2018 → Jan 2029 expected | adrenal cortex carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 3 | NCT00777244 | Apr 2008 → Dec 2018 | adrenal cortex carcinoma | University of Turin, Italy | Unknown | Missed primary |
| Phase 3 | NCT00304070 | May 2007 → Dec 2015 | adrenal cortex carcinoma | Children's Oncology Group | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT06333314 Comparator | Jul 2024 → Oct 2028 expected | adrenal cortex carcinoma, carcinoma of the ampulla of vater, duodenal adenocarcinoma, gastric adenocarcinoma +3 | UNICANCER | Recruiting | No outcome recorded |
| Phase 2 | NCT05913427 Background | Jun 2022 → Jun 2027 expected | adrenal cortex carcinoma | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Recruiting | No outcome recorded |
| Phase 3 | NCT00094497 Comparator | Jun 2004 → Dec 2010 | adrenal cortex carcinoma | Collaborative Group for Adrenocortical Carcinoma Treatment | Completed | No outcome recorded |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mitotane | “Etoposide-cisplatin-doxorubicin or mitotane” NCT06333314 ↗11“Mitomycin, Mitotane, Mitoxantrone” NCT02788201 ↗ |
| Known as | CB 313 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1670 ↗ |
| Known as | Chloditan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1670 ↗ |
| Known as | Chlodithane | ChEMBL registry synonym — accepted as the source's own label CHEMBL1670 ↗ |
| Known as | Lysodren | ChEMBL registry synonym — accepted as the source's own label CHEMBL1670 ↗ |
| Known as | Mitotan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1670 ↗ |
| Known as | Mitotane (Lysodren) | “Mitotane (Lysodren)” NCT00777244 ↗ |
| Known as | Mitotano | ChEMBL registry synonym — accepted as the source's own label CHEMBL1670 ↗ |
| Known as | NSC-38721 | “DDD Mitotane, NSC-38721” NCT00001339 ↗ |
| Known as | O,p'-ddd | ChEMBL registry synonym — accepted as the source's own label CHEMBL1670 ↗ |
| Known as | O,p'-ddd,o p'-tde | ChEMBL registry synonym — accepted as the source's own label CHEMBL1670 ↗ |
| Known as | O,p'-tde | ChEMBL registry synonym — accepted as the source's own label CHEMBL1670 ↗ |
| Known as | Opeprim | ChEMBL registry synonym — accepted as the source's own label CHEMBL1670 ↗ |
| Action | Inhibit | “an antagonist of P-glycoprotein” NCT00001339 ↗ |
| Modality | Small molecule | — CHEMBL1670 ↗ |
| Route | Oral | “daily oral mitotane” NCT00001339 ↗ |
| Target | CYP11A1 | “Cytochrome P450 11A1 inhibitor” CHEMBL1670 ↗ |
| Target | CYP11B1 | “Cytochrome P450 11B1 inhibitor” CHEMBL1670 ↗ |