mitotane
Trade name: lysodren
Approved
Jul 8, 1970
Mitotane is an oral chemotherapeutic agent indicated in the treatment of inoperable adrenal cortical carcinoma of both functional and nonfunctional types. Mitotane can best be described as an adrenal cytotoxic agent, although it can cause adrenal inhibition, apparently without cellular destruction. The administration of Mitotane alters the extra-adrenal metabolism of cortisol in man; leading to a reduction in measurable 17-hydroxy corticosteroids, even though plasma levels of corticosteroids do not fall. The drug apparently causes increased formation of 6-B-hydroxyl cortisol. Its biochemical mechanism of action is unknown, although data are available to suggest that the drug modifies the peripheral metabolism of steroids as well as directly suppressing the adrenal cortex. Mitotane is used for treatment of inoperable adrenocortical tumours; Cushing's syndrome — NCATS
Clinical trial activity
16 trials · 16 clinical orgs · 1 marketing orgs
Earliest trial started Aug 1, 1993 (NCT00001339)
Timeline
1970s
- Jul 8, 1970
HRA Pharma — Earliest FDA Approval
- Jul 8, 1970
HRA Pharma — Marketing Organization
- Jul 8, 1970
HRA Pharma — NDA Secondary Org
- Jul 8, 1970
HRA Pharma — NDA Organization
1990s
- Jan 1, 1993
Earliest Phase 2 Sponsor(trial)
2000s
- Jan 1, 2004
Earliest Phase 3 Sponsor(trial)
2010s
- Jan 1, 2013
Earliest Phase 1 Sponsor(trial)
Indications
Mechanism of action
- Cytochrome P450 11B1INHIBITOR
CYP11B1 inhibitor
- Cytochrome P450 11A1INHIBITOR
CYP11A1 inhibitor
Approval history
- approvedPriority reviewJul 8, 1970
Chemistry & pharmacology
SMILES
ClC(Cl)C(C1=CC=C(Cl)C=C1)C2=CC=CC=C2Cl- Mol. weight
- 320.041 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaMitotane ↗
- NCATS78E4J5IB5J ↗
- ChEMBLCHEMBL1967878 ↗
- ChEMBLCHEMBL1670 ↗
Also known as
- cb-313
- cb-313
- chloditan
- chlodithane
- lysodren
- lysodren
- lysodren
- lysodren
- mitotan
- mitotan
- mitotan
- mitotane
- mitotane
- mitotane
- mitotane
- mitotane
- mitotane
- mitotane
- mitotane
- mitotane
- mitotane
- mitotane
- mitotane
- mitotano
- mitotano
- mitotanum
- mitotanum
- opddd
- o,p'-ddd
- o,p'-ddd
- opeprim
- piprine-ddd, o-
- piprine-ddd, o-
- r-763
- r-763
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06831175 | Phase 2 | Feb 15, 2025 | Sichuan University |
| NCT05634577 | Phase 2 | Jan 2, 2023 | University of Texas at Houston |
| NCT05913427 | Phase 2 | Jun 8, 2022 | Spedali Civili di Brescia |
| NCT04123886 | Phase 1 | Oct 18, 2019 | Sichuan Clover Biopharmaceuticals, Inc. |
| NCT04047771 | Phase 1 | Aug 31, 2019 | Sichuan Clover Biopharmaceuticals, Inc. |
| NCT04051112 | Phase 1 | Jul 30, 2019 | Sichuan Clover Biopharmaceuticals, Inc. |
| NCT03869697 | Phase 1 | Mar 17, 2019 | Clover Biopharmaceuticals |
| NCT03583710 | Phase 3 | Aug 20, 2018 | Amercian Australian Asian Adrenal Alliance (A5), European Network for the Study of Adrenal Tumors (ENS@T), University of Texas at Houston, University of Turin |
| NCT03723941 | Phase 3 | Jul 1, 2018 | University of Brescia |
| NCT03443674 | Phase 1 | Jun 18, 2018 | Clover Biopharmaceuticals |
| NCT02057237 | Phase 1 | Sep 1, 2013 | University of Toronto |
| NCT00778817 | Phase 2 | Dec 1, 2008 | National Cancer Institute (NCI), University of Chicago |
| NCT00777244 | Phase 3 | Apr 1, 2008 | Julius-Maximilians University, University of Turin |
| NCT00304070 | Phase 3 | Sep 1, 2006 | National Cancer Institute (NCI) |
| NCT00094497 | Phase 3 | Jun 1, 2004 | Collaborative Group for Adrenocortical Carcinoma Treatment, German Federal Ministry of Education and Research, National Cancer Institute (NCI), Uppsala University |
| NCT00001339 | Phase 2 | Aug 1, 1993 | National Cancer Institute (NCI) |
Organizations
Research & Development (16)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 4 | 3 | 2 | 1993 |
| Sichuan Clover Biopharmaceuticals, Inc. | For profit | 3 | 3 | 1 | 2019 |
| Clover Biopharmaceuticals | For profit | 2 | 2 | 1 | 2018 |
| University of Texas at Houston | Academic/Hospital | 2 | 2 | 2 | 2018 |
| University of Turin | Academic/Hospital | 2 | 1 | 1 | 2008 |
| Amercian Australian Asian Adrenal Alliance (A5) | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Collaborative Group for Adrenocortical Carcinoma Treatment | Academic/Hospital | 1 | 1 | 1 | 2004 |
| European Network for the Study of Adrenal Tumors (ENS@T) | Academic/Hospital | 1 | 0 | 1 | 2018 |
| German Federal Ministry of Education and Research | Government | 1 | 0 | 1 | 2004 |
| Julius-Maximilians University | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Sichuan University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Spedali Civili di Brescia | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of Brescia | Academic/Hospital | 1 | 1 | 1 | 2018 |
| University of Chicago | Academic/Hospital | 1 | 0 | 1 | 2008 |
| University of Toronto | Academic/Hospital | 1 | 1 | 1 | 2013 |
| Uppsala University | Academic/Hospital | 1 | 0 | 1 | 2004 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| HRA Pharma | For profit | MKTG | Jul 8, 1970 |
| HRA Pharma | For profit | NDA2 | Jul 8, 1970 |
| HRA Pharma | For profit | NDA | Jul 8, 1970 |