Mitotane is named as an intervention in 2 current clinical trials in our China, Germany, France, Sweden and Poland registers. 2 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is West China Hospital (1). The most-studied condition is Adrenal Cortical Carcinoma.
Of the three regulators tracked here, the first to approve Mitotane was the US, on 8 Jul 1970. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
NCT03583710 · ClinicalTrials.gov ↗ · ENSAT Stage I Adrenal Cortex Carcinoma, ENSAT Stage II Adrenal Cortex Carcinoma, ENSAT Stage III Adrenal Cortex Carcinoma
|
Phase 3 | Recruiting | M.D. Anderson Cancer Center | Germany, France, Sweden, Poland |
|
Phase II Study of PD-1 Inhibitor Combined With Apatinib and Mitotane in the Treatment of Advanced Adrenal Cortical Carcinoma
NCT06831175 · ClinicalTrials.gov ↗ · Adrenal Cortical Carcinoma, Adrenal Cortical Cancer, Adrenal Cancer
|
Phase 2 | Recruiting | West China Hospital | China |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
1 single-substance product containing Mitotane on the HPRA medicines list.
No entry for Mitotane in the EMA, FDA or German BfArM shortage lists we track.
| Lead sponsor | Trials |
|---|---|
| West China Hospital | 1 |
| M.D. Anderson Cancer Center | 1 |
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 1 | 1 |
| Clinical trials in Germany | 1 | 1 |
| Clinical trials in France | 1 | 1 |
| Clinical trials in Sweden | 1 | 1 |
| Clinical trials in Poland | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
2 current trials in our China, Germany, France, Sweden and Poland registers name Mitotane (also registered as 1-Chloro-2-[2) as a drug or biological intervention, as of the registry sync on 29 September 2026. Completed and withdrawn studies are not counted.
Yes. 2 of the 2 trials are recruiting: 1 with sites in China, 1 with sites in Germany, 1 with sites in France, 1 with sites in Sweden and 1 with sites in Poland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
West China Hospital (1) and M.D. Anderson Cancer Center (1). The number in brackets is how many trials each organisation leads.
Yes. The HPRA medicines list includes 1 single-substance product containing Mitotane, for example Lysodren 500mg tablets (Esteve Pharmaceuticals S.A.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Not in the lists we track: Mitotane has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Mitotane works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Mitotane works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Mitotane (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 29 Sep 2026.