# Orteronel

Source: https://onco.cc/drugs/orteronel/  
OnCo record `orteronel` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A more selective version of abiraterone that was meant to avoid the need for steroids. It delayed the cancer on scans but did not help men live longer, and was abandoned.

## Summary

Orteronel is a non-steroidal, partially selective inhibitor of CYP 17,20-lyase. The selectivity was the point: abiraterone inhibits both the 17-alpha-hydroxylase and the 17,20-lyase activities of CYP17, which is why it raises mineralocorticoids and has to be given with a corticosteroid. A lyase-selective inhibitor should avoid that.

ELM-PC 4 randomised 1,560 chemotherapy-naive men with metastatic castration-resistant prostate cancer at 324 centres in 43 countries to orteronel 400 mg with prednisone twice daily or placebo with prednisone. Median radiographic progression-free survival was 13.8 months against 8.7, hazard ratio 0.71 (95 percent confidence interval 0.63 to 0.80, p<0.0001), a large and unambiguous effect. Median overall survival was 31.4 against 29.5 months, hazard ratio 0.92 (0.79 to 1.08, p=0.31), which is nothing. The companion trial in men after docetaxel, ELM-PC 5, also missed overall survival.

Grade 3 or worse increases in lipase (17 against 2 percent) and amylase (10 against 1 percent) were the characteristic toxicities, along with fatigue and pulmonary embolism. Millennium, a Takeda subsidiary, stopped developing the drug. Orteronel is the reason the field treats radiographic progression-free survival in prostate cancer with suspicion as a surrogate for survival.

## Fields

- Kind: Treatment
- Status: withdrawn
- Last checked: 2026-09-25
- Also known as: TAK-700
- Code: TAK-700
- Modality: small molecule
- Mechanism: Non-steroidal, partially selective inhibitor of CYP 17,20-lyase, reducing extragonadal androgen synthesis.

## Sources

- ELM-PC 4 (Lancet Oncology 2015): https://doi.org/10.1016/S1470-2045(15)70027-6

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- targets: [CYP17A1 (17-alpha-hydroxylase/17,20-lyase)](https://onco.cc/targets/cyp17a1/)
- companies: [Takeda](https://onco.cc/companies/takeda/)
- terms: [Androgen receptor pathway inhibitor (ARPI)](https://onco.cc/terms/arpi/), [Castration-resistant prostate cancer (CRPC)](https://onco.cc/terms/castration-resistance/)
- trials: [ELM-PC 4](https://onco.cc/trials/elm-pc-4-orteronel/)

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JSON: https://onco.cc/api/v1/entities/orteronel.json