Drugs / Testosterone Cypionate
Testosterone Cypionate
also known as
DEPo-Testosterone Injection · Andro-cyp · Azmiro · Depo-testosterone · Depotest · NSC-9157 · Testosterone 17.beta.-cyclopentanepropionate · Testosterone cipionate · +2 more
Small molecule targets AR via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | TESTOSTERONE CYPIONATE | — | 1978-06-23 | fda.gov ↗ |
Trials 29
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06305598 | Dec 2024 → Dec 2029 expected | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Roswell Park Cancer Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT04731376 | Jan 2021 → Nov 2024 overdue | hypogonadism, male, malignant urinary system neoplasm | Emory University | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01378299 | Oct 2011 → Nov 2016 | hypogonadism, male | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 216 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT07142551 | Mar 2026 → Jun 2030 expected | castration-resistant prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT07476001 | Mar 2026 → Sep 2027 expected | prostate carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06922318 | Aug 2025 → Aug 2031 expected | castration-resistant prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT06039371 | May 2024 → Mar 2027 expected | castration-resistant prostate carcinoma, prostate adenocarcinoma | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT06100705 | Dec 2023 → Dec 2027 expected | castration-resistant prostate carcinoma | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT06059118 | Oct 2023 → Jan 2027 expected | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT04895306 | Nov 2022 → Mar 2026 | hypogonadism, substance-related disorder | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04704505 | Apr 2022 → Feb 2028 expected | castration-resistant prostate carcinoma, prostate adenocarcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT04558866 | Jun 2021 → Mar 2024 overdue | prostate cancer | Latin American Cooperative Oncology Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04424654 | Sep 2020 → May 2022 | prostate cancer | Hospital Sirio-Libanes | Completed | No outcome recorded |
| Phase 2 | NCT04363164 | Aug 2020 → Jul 2027 expected | castration-resistant prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT03554317 | Sep 2018 → Oct 2022 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | Met primary |
| Phase 2 | NCT03516812 | Aug 2018 → Mar 2021 | castration-resistant prostate carcinoma, prostate adenocarcinoma | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT02286921 | Jan 2015 → Oct 2018 | castration-resistant prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | Missed primary |
| Phase 2 | NCT02090114 | Aug 2014 → Nov 2021 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | Met primary |
| Phase 2 | NCT01750398 | Jan 2013 → Jun 2015 | prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07852195 | Jan 2027 → Mar 2029 expected | prostate adenocarcinoma | ECOG-ACRIN Cancer Research Group | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT03038919 | Oct 2016 → Oct 2017 | critical illness polyneuropathy | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT07278362 | May 2026 → May 2031 expected | hypogonadism, male, prostate cancer | University of Miami | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07328542 | Feb 2026 → Jun 2027 expected | hypogonadism, male | Azurity Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06592144 | Sep 2024 → Aug 2026 overdue | myopathy | Leticia Maria Defendi Barboza Marson | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04321551 | Jul 2023 → Jun 2028 | — | University of California, San Diego | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03325647 | Nov 2017 → May 2021 | Klinefelter syndrome | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 4 | NCT02408445 | May 2015 → Jan 2018 | Klinefelter syndrome | University of Colorado, Denver | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07568574 | Mar 2026 → May 2028 expected | — | Enhanced Emirates Limited | Enrolling by invitation | No outcome recorded |
| — | NCT05487794 | Sep 2022 → Nov 2024 | hematologic disorder | University of Sao Paulo | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT02995330 Background | Feb 2017 → Jun 2021 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06111209 Comparator | Feb 2025 → Dec 2026 expected | female stress incontinence | Brigham and Women's Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03716739 Comparator | Mar 2019 → May 2025 | prostate cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00853502 Comparator | Dec 2008 → Oct 2016 | metabolic bone disorder | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT07092527 Comparator | Dec 2025 → Nov 2028 expected | reproductive system disorder | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 4 | NCT06450405 Comparator | Feb 2025 | reproductive system disorder | University of California, San Diego | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT04439799 Comparator | Aug 2020 → Feb 2023 | hypogonadism, male | University of Miami | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-04-13 | Xiromed LLC | Regulatory Xiromed LLC Launches Testosterone Cypionate Injection, USP xiromed.com ↗
Xiromed LLC today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Testosterone Cypionate Injection, USP, generic to Depo-Testosterone®. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-04-13 | Xiromed LLC | Xiromed LLC Launches Testosterone Cypionate Injection, USP xiromed.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Testosterone Cypionate | “Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic...” NCT04321551 ↗35“All Patients will receiveTestosterone Cypionate 400mg IM every 28 days, until progression or unacceptable toxicity.” NCT04704505 ↗ |
| Known as | Andro-cyp | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201101 ↗ |
| Known as | Azmiro | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201101 ↗ |
| Known as | Depo-testosterone | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201101 ↗ |
| Known as | DEPo-Testosterone Injection | “DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic...” NCT01378299 ↗1“Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone.” NCT04363164 ↗ |
| Known as | Depotest | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201101 ↗ |
| Known as | NSC-9157 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201101 ↗ |
| Known as | Testosterone 17.beta.-cyclopentanepropionate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201101 ↗ |
| Known as | Testosterone cipionate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201101 ↗ |
| Known as | Testosterone cypionate ciii | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201101 ↗ |
| Known as | Testosterone cypionate component of depo-testadiol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201101 ↗ |
| Action | Activate | “Androgen Receptor agonist” CHEMBL1201101 ↗ |
| Modality | Small molecule | — CHEMBL1201101 ↗ |
| Route | Intramuscular | “dose dependent on pubertal stage, intramuscular injection once every 3 weeks for 12 months” NCT00853502 ↗ |
| Target | AR | “Androgen Receptor agonist” CHEMBL1201101 ↗ |