Bleomycin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | BLENOXANE | — | 1996-02-20 | fda.gov ↗ |
| Approved | US (FDA) | BLENOXANE | — | 1973-07-31 | fda.gov ↗ |
Trials 137 · started per year
Also used as a comparator or background therapy in 51 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT01060904 Background | Jan 2010 → Sep 2012 | Hodgkins lymphoma | Seagen Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00993512 Background | Aug 2009 → May 2011 | head and neck neoplasm, skin neoplasm | PCI Biotech AS | Completed | No outcome recorded |
| Phase 1 | NCT00000689 Background | ? → Mar 1991 | HIV infectious disease, non-Hodgkin lymphoma | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00000681 Background | ? → Oct 1993 | HIV infectious disease, Kaposi's sarcoma | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03033914 Background | Jan 2017 → Jan 2027 expected | classic Hodgkin lymphoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 218 trials | ||||||
| Phase 2 | NCT07320001 Comparator | Jan → Jul 2026 overdue | lymphatic malformation | Basharat Hussain | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03830385 Background | Feb 2019 → Feb 2021 | head and neck squamous cell carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT03407144 Background | Apr 2018 → Nov 2026 expected | classic Hodgkin lymphoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03527628 Background | Jan 2018 → Jan 2021 | classic Hodgkin lymphoma | King Abdullah International Medical Research Center | Unknown | No outcome recorded |
| Phase 2 | NCT03088059 Background | Nov 2017 → Jun 2025 | head and neck squamous cell carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Unknown | No outcome recorded |
| Phase 2 | NCT02883023 Comparator | Nov 2016 → Jan 2018 | capillary malformation, vascular malformation | Sophie Horbach | Unknown | No outcome recorded |
| Phase 2 | NCT02298283 Background | Apr 2015 → Jul 2020 | Hodgkins lymphoma | The Lymphoma Academic Research Organisation | Completed | No outcome recorded |
| Phase 2 | NCT02292979 Comparator | Mar 2015 → Dec 2016 | Hodgkins lymphoma | The Lymphoma Academic Research Organisation | Completed | No outcome recorded |
| Phase 2 | NCT02784054 Background | Apr 2014 → Mar 2021 | central nervous system nongerminomatous germ cell tumor | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT01941901 Comparator | Sep 2013 → Sep 2016 | — | Herlev Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01873326 Comparator | Jun 2013 → Jun 2027 expected | germ cell tumor | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02275598 Background | Apr → Nov 2013 | Hodgkins lymphoma | University of Modena and Reggio Emilia | Unknown | No outcome recorded |
| Phase 2 | NCT00797472 Comparator | Jul 2011 → Apr 2014 | Hodgkins lymphoma | American Scitech International | Unknown | No outcome recorded |
| Phase 2 | NCT00654732 Background | Mar 2008 → Sep 2018 | classic Hodgkin lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00352027 Background | Jul 2006 → May 2015 | Hodgkins lymphoma | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00079105 Comparator | Jan 2004 → Dec 2010 | lymphoma | Newcastle-upon-Tyne Hospitals NHS Trust | Completed | No outcome recorded |
| Phase 2 | NCT02161692 Comparator | Dec 1996 → May 2007 | germ cell tumor, neoplasm of testis | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Completed | No outcome recorded |
| Phase 2 | NCT01404936 Background | Jul 1996 → Dec 2011 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00003643 Background | Oct 1998 → ? | extragonadal germ cell tumor, teratoma, testicular germ cell tumor | European Organisation for Research and Treatment of Cancer - EORTC | Unknown | No outcome recorded |
| Phase 318 trials | ||||||
| Phase 3 | NCT04685616 Comparator | Apr 2022 → Sep 2030 expected | Hodgkins lymphoma | University College, London | Recruiting | No outcome recorded |
| Phase 3 | NCT03067181 Background | May 2017 → Jun 2027 expected | childhood germ cell tumor, choriocarcinoma of ovary, choriocarcinoma of testis, malignant teratoma +7 | Children's Oncology Group | Recruiting | No outcome recorded |
| Phase 3 | NCT02661503 Comparator | Jul 2016 → Dec 2022 | classic Hodgkin lymphoma | University of Cologne | Unknown | No outcome recorded |
| Phase 3 | NCT02429687 Comparator | Apr 2015 → May 2025 overdue | malignant germ cell tumor of ovary | Beihua Kong | Recruiting | No outcome recorded |
| Phase 3 | NCT02429700 Comparator | Apr 2015 → May 2025 overdue | ovarian cancer, ovarian sex cord-stromal tumor | Beihua Kong | Recruiting | No outcome recorded |
| Phase 3 | NCT02166463 Comparator | Mar 2015 → Dec 2021 overdue | classic Hodgkin lymphoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01712490 Comparator | Nov 2012 → Apr 2017 | Hodgkins lymphoma | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01659099 Background | Sep 2012 → Aug 2016 | diffuse large B-cell lymphoma | The Lymphoma Academic Research Organisation | Terminated | No outcome recorded |
| Phase 3 | NCT01356680 Background | Jan 2012 → Mar 2020 | Hodgkins lymphoma | University of Cologne | Completed | No outcome recorded |
| Phase 3 | NCT00816959 Comparator | Jul 2011 → Apr 2014 | Hodgkins lymphoma | American Scitech International | Unknown | No outcome recorded |
| Phase 3 | NCT01358747 Comparator | May 2011 → ? | Hodgkins lymphoma | Centre Hospitalier Universitaire Dijon | Completed | No outcome recorded |
| Phase 3 | NCT00736320 Background | Nov 2009 → Sep 2018 | Hodgkins lymphoma | University of Cologne | Unknown | No outcome recorded |
| Phase 3 | NCT00038558 Background | Nov 2001 → Feb 2004 | Hodgkins lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT01251107 Comparator | Mar 2000 → Nov 2009 | Hodgkins lymphoma | Fondazione Michelangelo | Completed | No outcome recorded |
| Phase 3 | NCT00264953 Background | May 1998 → Jan 2003 | Hodgkins lymphoma | University of Cologne | Completed | No outcome recorded |
| Phase 3 | NCT00577993 Comparator | Mar 1998 → Aug 2017 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00005578 Background | Mar 1997 → Oct 2004 | chemotherapy-induced toxicity, lymphoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00002561 Comparator | Jan 1994 → Aug 2011 | Hodgkins lymphoma | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT04582305 Comparator | Mar → Nov 2022 | keloid | Erasmus Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT03477448 Comparator | Apr 2018 → Apr 2019 | plantar wart | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT02526823 Comparator | Aug 2015 → Dec 2019 | lymphoma | Shandong Provincial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01347294 Comparator | Aug 2011 → Nov 2023 | vascular malformation | Oslo University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00380770 Comparator | Jan 2003 → Feb 2009 | AIDS, Kaposi's sarcoma, human herpesvirus 8 infection | University of KwaZulu | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07041749 Comparator | Jun 2026 → Jun 2027 expected | plantar wart | Assiut University | Not yet recruiting | No outcome recorded |
| — | NCT07498959 Comparator | Mar 2026 → Mar 2031 expected | testicular seminoma | Sahlgrenska University Hospital | Recruiting | No outcome recorded |
| — | NCT05057663 Comparator | Nov 2021 → Mar 2022 | plantar wart | Sohag University | Unknown | No outcome recorded |
| — | NCT00066482 Background | Jul 2004 → Apr 2007 | childhood germ cell tumor, extragonadal germ cell tumor | Children's Oncology Group | Completed | No outcome recorded |
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 189 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bleomycin | “Chemotherapy is based upon regimes with well known effectiveness in Hodgkin lymphoma. (i.e. ABVD: doxorubicin, bleomycin, vinblastine and dacarbazine and ESHAP: Etoposide,...” NCT03500133 ↗164“The other half (Group II) will receive a combination of intravenous Adriamycin, Bleomycin, Vinblastine and Dacarbazine every other week for 12 treatments.” NCT00797472 ↗ “Doxorubicin 25 mg/m2 IV, Bleomycin 10,000 units/m2 IV, Vinblastine 6 mg/m2 IV, Dacarbazine 375 mg/m2 IV on days 1-15 of each 28 day cycle.” NCT02275598 ↗ “BACOPP-D regimen which includes cyclophosphamide, adriamycin, dacarbazine, procarbazine, prednisolone, bleomycin and vincristine” NCT00188149 ↗ “Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle” NCT00901303 ↗ “doxorubicin 25 mg/m\^2 IV bleomycin 10 units/m\^2 IV vinblastine 6 mg/m\^2 IV dacarbazine 375 mg/m\^2 IV” NCT01118026 ↗ “BEACOPPescalated consisted of bleomycin 10 mg/m2 and vincristine 1·4 mg/m2 intravenously on day 8” PMID 30658935 ↗ Jan 2019 “doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD)-based response-adapted therapy” NCT01652261 ↗ “Adriamycin 25mg/m2, Bleomycin10,000units/m2, Vinblastine 6mg/m2 and Dacarbazine 375mg/m2” NCT03527628 ↗ “Bleomycin (B) 5units/m2/day IV over 10min on Day 1 10units/m2/day IV over 10min on Day 8” NCT01858922 ↗ “vincristine sulfate IV and bleomycin IV on day 1 of weeks 2, 4, 6, and 8” NCT00846742 ↗ “Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles” NCT01578967 ↗ “Bleomycin hydrochloride injection: 10mg/m2, IV or IM, day 8” NCT02800447 ↗ “Bleomycin 30,000 IU IV infusion - days 1 (or 2), 8, 15” NCT01726374 ↗ “Adriamycin, Bleomycin, Vinblastine and Dacarbazine” NCT00816959 ↗ “Bleomycin 30 mg/day IV or IM D1, D8, and D15.” NCT05705687 ↗ “Bleomycin 10 mg/m2 i.v./i.m. day 1 and 15” NCT00433433 ↗ “bleomycin together with electroporation” NCT01479946 ↗ “Bleomycin 10 mg/m2 i.v. day 1 and 15” NCT00784537 ↗ “Bleomycin 10 mg/mq i.v. day 1 and 15” NCT01523847 ↗ “Bendamustine, Bleomycin, Bortezomib” NCT02788201 ↗ “Bleomycin 10 mg/m2 i.v. day 1 and 8” NCT02247869 ↗ “Intramuscular Bleomycin 10 U/m2” NCT00380770 ↗ “Bleomycin：10 mg/m2，ivgtt，D1、15；” NCT02526823 ↗ “Bleomycin, Etoposide, Platinum” NCT07498959 ↗ “Bleomycin 10mg/m2 IV in day 8” NCT01304849 ↗ “Bleomycin 7mg day 1-5” NCT00190528 ↗ “bleomycin 10 mg/m2/D” NCT00970385 ↗ “Bleomycin” NCT00592111 ↗ |
| Known as | Blenamax | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067492 ↗ |
| Known as | Blenoxane | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067492 ↗ |
| Known as | BLEO | “Bleomycin, BLEO, NSC-125066” NCT00002462 ↗1“BLEO Bleomycin, NSC-125066” NCT00002565 ↗ |
| Known as | Bleocin | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067492 ↗ |
| Known as | Bleomicina | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01067690 ↗ |
| Known as | Bleomicine | “Esc.BEACOPP Bleomicine10 mg/m2/ev/die 8°” NCT00795613 ↗ |
| Known as | Bleomycin (as bleomycin sulfate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067492 ↗ |
| Known as | Bleomycin (B) | “Bleomycin (B)” NCT01858922 ↗ |
| Known as | Bleomycin hexal | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067492 ↗ |
| Known as | Bleomycin hydrochloride | “Bleomycin hydrochloride injection: 10mg/m2, IV or IM, day 8” NCT02800447 ↗ |
| Known as | Bleomycin PHC 15 e. | “Bleomycin PHC 15 e. (United States Pharmacopeia - USP)” NCT02352259 ↗ |
| Known as | Bleomycin Sulfate | “The MedPulser device will be used in combination with Bleomycin Sulfate injection around the tumor area in a concentration of 1 U/ml per cm3 of tumor treatment area.” NCT00198276 ↗30“Patients receive injections of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area followed by electroporation.” NCT00198328 ↗ “Bleomycin sulfate was administered at a dose of 15 units/m\^2 over 10 minutes every 3 weeks.” NCT01435018 ↗ “Bleomycin (active name: Bleomycin Sulfate)” NCT02582697 ↗ “Biological: bleomycin sulfate” NCT00002571 ↗ “Biological: Bleomycin sulfate” NCT00002715 ↗ “Biological: bleomycin sulfate” NCT00678327 ↗ “Biological: Bleomycin Sulfate” NCT00025259 ↗ “Biological: bleomycin sulfate” NCT00049595 ↗ “Biological: bleomycin sulfate” NCT00079105 ↗ “Biological: bleomycin sulfate” NCT00005090 ↗ “Biological: bleomycin sulfate” NCT00002565 ↗ “Drug: Bleomycin Sulfate” NCT07579962 ↗ |
| Known as | Bleomycin sulphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067492 ↗ |
| Known as | Bleomycine | “Methotrexate, Paclitaxel, Docetaxel, Carboplatin, 5-Fluorouracil, Bleomycine, Gemcitabine, Mitomycine or Best supportive care” NCT03088059 ↗ |
| Known as | Bleomycini sulfas | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067492 ↗ |
| Known as | Bleomycins | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067492 ↗ |
| Known as | Bleomycins sulfate | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067492 ↗ |
| Known as | Blexane | ChEMBL registry synonym — accepted as the source's own label CHEMBL6067492 ↗ |
| Known as | NSC-125066 | “Bleomycin, BLEO, NSC-125066” NCT00002462 ↗ |
| Action | Inhibit | “Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells” NCT00654732 ↗ |
| Route | Intravenous | “Four medicines are given on day 1 of each cycle by vein (IV) (doxorubicin, cyclophosphamide, bleomycin, vincristine).” NCT00000689 ↗ |