Drugs / Tamoxifen
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Tamoxifen

Small molecule targets ESR1

Developed for
breast cancer · female breast carcinoma · estrogen-receptor positive breast cancer · hormone receptor-positive breast cancer · Her2-receptor negative breast cancer · breast neoplasm · ductal breast carcinoma in situ · invasive breast carcinoma
+104 more · lobular breast carcinoma in situ · progesterone-receptor positive breast cancer · central nervous system neoplasm · ovarian carcinoma · amyotrophic lateral sclerosis · atypical lobular breast hyperplasia · breast carcinoma · cancer · fallopian tube cancer · infertility disorder · peritoneum cancer · prostate cancer · sarcoma · Duchenne muscular dystrophy · glioblastoma · HIV infectious disease · liver cancer · lung disorder · male breast carcinoma · menstrual disorder · metastatic neoplasm · ovarian cancer · urinary bladder cancer · adrenal cortex carcinoma · ATM-related cancer predisposition · atypical teratoid rhabdoid tumor · Barrett esophagus · benign mammary dysplasia · bipolar disorder · brain neoplasm · breast carcinoma in situ · breast fibroadenoma · breast fibrocystic disease · breast lobular carcinoma · central nervous system cancer · cervical squamous cell carcinoma · CHEK2-related cancer predisposition · childhood medulloblastoma · chronic hepatitis C virus infection · coronary artery disorder · cutaneous melanoma · cystic fibrosis · desmoid tumor · diffuse large B-cell lymphoma · digestive system neoplasm · embryonal tumor with multilayered rosettes · endometrial cancer · endometrial carcinoma · endometrial disorder · ependymoblastoma · exocrine pancreatic carcinoma · fallopian tube carcinoma · female infertility · glioma · head and neck cancer · hemometra · hemorrhagic disease · hereditary hemorrhagic telangiectasia · heritable pulmonary arterial hypertension · hyperplasia · hypertensive disorder · hypogonadism · malignant epithelial tumor of ovary · malignant mesothelioma · malignant pancreatic neoplasm · Mammastatin · medulloblastoma non-WNT/non-SHH group 3 · medulloblastoma non-WNT/non-SHH group 4 · medulloepithelioma · metastatic carcinoma in the bone · metastatic malignant neoplasm · myocardial ischemia · neuroblastoma · neuroendocrine neoplasm · ocular melanoma · oligoasthenoteratozoospermia · osteosarcoma · pancreatic mucinous-cystic neoplasm · peritoneal carcinoma · pheochromocytoma · pineoblastoma · polycystic ovary syndrome · prostate carcinoma · refractory malignant neoplasm · skin atrophy · triple-negative breast carcinoma · urinary bladder neoplasm · urothelial carcinoma · uterine corpus cancer · X-linked myotubular myopathy · basal-like breast carcinoma · CDH1-related diffuse gastric and lobular breast cancer syndrome · COVID-19 · gynecomastia disorder · luminal B breast carcinoma · manic bipolar affective disorder · meningitis · ovarian serous adenocarcinoma · PALB2-related cancer predisposition · primary peritoneal serous adenocarcinoma · RAD51C-related cancer predisposition · RAD51D-related cancer predisposition · schizoaffective disorder · uterine disorder
Investigated by
National Cancer Institute (NCI) · AstraZeneca · Pfizer · Merck Sharp & Dohme LLC · Dana-Farber Cancer Institute · ETOP IBCSG Partners Foundation
+253 more · Eli Lilly and Company · Sun Yat-sen University · University of California, San Francisco · Cancer and Leukemia Group B · Fudan University · NCIC Clinical Trials Group · Novartis · Oregon Health and Science University · European Organisation for Research and Treatment of Cancer - EORTC · Institut Cancerologie de l'Ouest · Institut Claudius Regaud · Mayo Clinic · Novartis Pharmaceuticals · San Diego Pacific Oncology & Hematology Associates · Scottish Cancer Therapy Network · Washington University School of Medicine · Alliance for Clinical Trials in Oncology · Andrea DeCensi · Breast Cancer Research Foundation · Breast International Group · Danish Breast Cancer Cooperative Group · Emory University · GBG Forschungs GmbH · Gynecologic Oncology Group · H. Lee Moffitt Cancer Center and Research Institute · International Collaborative Cancer Group · Karolinska Institutet · Korean Breast Cancer Study Group · Medical College of Wisconsin · NRG Oncology · NSABP Foundation Inc · Nalagenetics Pte Ltd · National Medical Research Council (NMRC), Singapore · North Central Cancer Treatment Group · Ottawa Hospital Research Institute · Radiation Therapy Oncology Group · SOLTI Breast Cancer Research Group · SWOG Cancer Research Network · UNICANCER · University Health Network, Toronto · University of Colorado, Denver · University of Nebraska · University of Rochester · University of Washington · University of Wisconsin, Madison · Wake Forest University · AC Camargo Cancer Center · AEterna Zentaris · AGO Study Group · AHS Cancer Control Alberta · ALS Therapy Alliance · AMS Advanced Medical Services GmbH · ARC Foundation for Cancer Research · ARCAGY/ GINECO GROUP · Agendia · Ain Shams University · Al-Thawra Modern General Hospital · Amgen · Anthony Joshua, FRACP · Asan Medical Center · Associazione Italiana per la Ricerca sul Cancro · Austrian Breast & Colorectal Cancer Study Group · Avon Foundation · Azienda Ospedaliera Universitaria Integrata Verona · Bader, Ted, M.D. · Baylor Breast Care Center · Baylor College of Medicine · Big Ten Cancer Research Consortium · Breast Cancer Trials, Australia and New Zealand · Brigham and Women's Hospital · British Association of Surgical Oncology: Breast Group · British Columbia Cancer Agency · Buddhist Tzu Chi General Hospital · C17 Council · all 259 on the full record

Regulatory milestones approvals, filings & regulatory actions · 11 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) SOLTAMOX — 2018-09-25 fda.gov ↗
Label expansions (9) US (FDA) NOLVADEX — 1986-12-03 – 2009-03-13 fda.gov ↗
Approved US (FDA) NOLVADEX — 1977-12-30 fda.gov ↗

Trials 223 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT06942039 Sep 2025 → Dec 2030 expected atypical teratoid rhabdoid tumor, childhood medulloblastoma, embryonal tumor with multilayered rosettes, ependymoblastoma +5 C17 Council Recruiting No outcome recorded
Phase 0 NCT04174352 Oct 2020 → Dec 2026 expected estrogen-receptor positive breast cancer University of Wisconsin, Madison Recruiting No outcome recorded
Phase 0 NCT02089386 Jul 2014 → Jun 2016 Barrett esophagus Washington University School of Medicine Terminated No outcome recorded Stop: Business
Phase 117 trials
Phase 1 NCT06320990 Jan 2025 → Nov 2028 expected pancreatic mucinous-cystic neoplasm University of Nebraska Recruiting No outcome recorded
Phase 1 NCT05156892 Sep 2022 → Jan 2026 overdue ovarian carcinoma Anthony Joshua, FRACP Active not recruiting No outcome recorded
Phase 1 NCT04200066 Jun 2022 → Oct 2023 brain neoplasm, glioblastoma University of Rochester Withdrawn No outcome recorded
Phase 1 NCT04961632 Dec 2020 → Nov 2025 breast cancer National Cancer Centre, Singapore Unknown No outcome recorded
Phase 1 NCT04433494 Dec 2020 → May 2023 breast cancer TYK Medicines, Inc Unknown No outcome recorded
Phase 1 NCT03554044 Feb 2020 → Dec 2023 Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, invasive breast carcinoma University of California, San Francisco Completed No outcome recorded
Phase 1 NCT02835079 Nov 2016 → Nov 2020 Duchenne muscular dystrophy Hadassah Medical Organization Completed No outcome recorded
Phase 1 NCT02513849 Dec 2015 → Aug 2018 cancer, digestive system neoplasm University of Nottingham Unknown No outcome recorded
Phase 1 NCT02333370 Feb 2015 → Sep 2022 hormone receptor-positive breast cancer Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02093351 Sep 2014 → Apr 2015 cancer AstraZeneca Completed No outcome recorded
Phase 1/27 trials · 1 missed
Phase 1/2 NCT05378269 Nov 2021 → Dec 2022 skin atrophy Daré Bioscience, Inc. Completed No outcome recorded
Phase 1/2 NCT04915846 Dec 2020 → May 2024 X-linked myotubular myopathy James Dowling Terminated No outcome recorded
Phase 1/2 NCT03280563 Dec 2017 → Sep 2024 breast neoplasm Hoffmann-La Roche Completed Missed primary
Phase 1/2 NCT04079517 Mar 2015 → Feb 2016 breast cancer Karolinska Institutet Completed No outcome recorded
Phase 1/2 NCT02166944 Apr 2014 → Sep 2019 amyotrophic lateral sclerosis Taipei Medical University Shuang Ho Hospital Completed No outcome recorded
Phase 1/2 NCT01194908 Jul 2010 → Jan 2014 breast cancer Emory University Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT00290745 Feb 2002 → Jul 2009 breast cancer University of California, San Francisco Completed Mixed
Phase 2108 trials · 5 met primary · 8 missed
Phase 2 NCT07499999 Sep 2026 → Aug 2027 expected ATM-related cancer predisposition, BRCA2-related cancer predisposition, CHEK2-related cancer predisposition, atypical lobular breast hyperplasia +1 Dana-Farber Cancer Institute Not yet recruiting No outcome recorded
Phase 2 NCT07806630 Sep 2026 → Jul 2028 expected invasive breast carcinoma Rutgers, The State University of New Jersey Active not recruiting No outcome recorded
Phase 2 NCT07535905 Jul 2026 → Oct 2030 expected hypogonadism, prostate cancer University Health Network, Toronto Not yet recruiting No outcome recorded
Phase 2 NCT07483307 Mar 2026 → Mar 2030 expected Her2-receptor negative breast cancer, breast lobular carcinoma, estrogen-receptor positive breast cancer Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT06434064 Mar 2026 → Nov 2028 expected triple-negative breast carcinoma Roswell Park Cancer Institute Recruiting No outcome recorded
Phase 2 NCT07289035 Jan → Apr 2026 overdue cystic fibrosis Azienda Ospedaliera Universitaria Integrata Verona Not yet recruiting No outcome recorded
Phase 2 NCT06364267 Oct 2025 → Jan 2027 expected breast cancer Andrea DeCensi Recruiting No outcome recorded
Phase 2 NCT06979596 Aug 2025 → Nov 2027 expected cancer Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 2 NCT06195306 Jul 2025 → Jan 2027 expected ductal breast carcinoma in situ, lobular breast carcinoma in situ National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 2 NCT06630325 Jun 2025 → Mar 2026 exocrine pancreatic carcinoma, female breast carcinoma, ovarian carcinoma, prostate carcinoma +1 OHSU Knight Cancer Institute Terminated No outcome recorded
Phase 2/34 trials
Phase 2/3 NCT06355401 Apr 2024 → Mar 2026 overdue diffuse large B-cell lymphoma Sohag University Not yet recruiting No outcome recorded
Phase 2/3 NCT02801786 Nov 2018 → Nov 2020 — Federal University of Goiás Unknown No outcome recorded
Phase 2/3 NCT03373708 Dec 2017 → Dec 2019 breast cancer Zhiyong Yu Unknown No outcome recorded
Phase 2/3 NCT02132000 Apr 2014 → May 2020 hormone receptor-positive breast cancer Fengxi Su Unknown No outcome recorded
Phase 358 trials · 7 met primary · 8 missed
Phase 3 NCT07502820 Mar 2026 → Aug 2036 expected female breast carcinoma Karolinska Institutet Not yet recruiting No outcome recorded
Phase 3 NCT07671885 Jan 2026 → Jan 2038 expected breast cancer Tokyo Women's Medical University Recruiting No outcome recorded
Phase 3 NCT07153757 Sep 2025 → Sep 2033 expected female breast carcinoma Fudan University Not yet recruiting No outcome recorded
Phase 3 NCT06223698 May 2025 → May 2032 expected breast cancer Region Örebro County Not yet recruiting No outcome recorded
Phase 3 NCT06671912 Feb 2025 → Nov 2030 Her2-receptor negative breast cancer, ductal breast carcinoma in situ, estrogen-receptor positive breast cancer, lobular breast carcinoma in situ Alliance for Clinical Trials in Oncology Suspended No outcome recorded
Phase 3 NCT06492616 Sep 2024 → Aug 2029 expected breast cancer Stemline Therapeutics, Inc. Recruiting No outcome recorded
Phase 3 NCT06507618 Jul 2024 → Jun 2029 expected female breast carcinoma University of Virginia Recruiting No outcome recorded
Phase 3 NCT07616973 May 2023 → May 2026 overdue female infertility Sana'a University Active not recruiting No outcome recorded
Phase 3 NCT05016349 Aug → Oct 2021 female breast carcinoma Mahmoud Ramadan mohamed Elkazzaz Unknown No outcome recorded
Phase 3 NCT04046159 Apr 2019 → Dec 2025 ductal breast carcinoma in situ National Taiwan University Hospital Unknown No outcome recorded
Phase 415 trials · 1 met primary
Phase 4 NCT05333328 Feb 2023 → Jan 2031 expected Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer Gangnam Severance Hospital Recruiting No outcome recorded
Phase 4 NCT05525481 Nov 2022 → Dec 2023 estrogen-receptor positive breast cancer Erasmus Medical Center Unknown No outcome recorded
Phase 4 NCT03948568 Sep 2019 → Jun 2021 female breast carcinoma Ottawa Hospital Research Institute Completed No outcome recorded
Phase 4 NCT03238703 Sep 2018 → Mar 2023 Her2-receptor negative breast cancer, breast carcinoma in situ, female breast carcinoma, invasive breast carcinoma Fred Hutchinson Cancer Center Withdrawn No outcome recorded Stop: Enrollment
Phase 4 NCT03355157 Mar 2018 → Aug 2024 breast cancer GBG Forschungs GmbH Completed No outcome recorded
Phase 4 NCT03060304 Mar 2017 → Dec 2019 endometrial disorder Sun Yat-sen University Unknown No outcome recorded
Phase 4 NCT02903121 Jan 2017 → Jun 2019 hemorrhagic disease Oregon Health and Science University Completed No outcome recorded
Phase 4 NCT02690870 Jan 2017 → May 2018 infertility disorder Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Unknown No outcome recorded
Phase 4 NCT02824224 Sep 2016 → Jan 2018 hemometra, menstrual disorder Oregon Health and Science University Completed No outcome recorded
Phase 4 NCT02479256 Jun 2015 → May 2016 polycystic ovary syndrome Ain Shams University Completed No outcome recorded
Phase not applicable11 trials
— NCT05501158 Jan 2021 → Apr 2024 breast cancer Nalagenetics Pte Ltd Unknown No outcome recorded
— NCT04312347 Sep 2019 → May 2021 estrogen-receptor positive breast cancer Nalagenetics Pte Ltd Completed No outcome recorded
— NCT02979301 Mar 2017 → Feb 2018 — Mayo Clinic Completed No outcome recorded
— NCT01293032 Apr 2011 → May 2015 ductal breast carcinoma in situ, female breast carcinoma, lobular breast carcinoma in situ Virginia Commonwealth University Completed No outcome recorded
— NCT01075802 Mar 2010 → Oct 2012 Amobarbital, deficient N-hydroxylation of, breast cancer Western Sydney Local Health District Completed No outcome recorded
— NCT00847366 May 2008 → Dec 2012 breast cancer, non-small cell lung carcinoma, sarcoma AEterna Zentaris Completed No outcome recorded
— NCT00538330 Sep 2007 → Sep 2020 breast cancer King Faisal Specialist Hospital & Research Center Unknown No outcome recorded
— NCT00449514 May 2007 → ? infertility disorder Shaare Zedek Medical Center Unknown No outcome recorded
— NCT01016665 Apr 2005 → Jul 2007 breast cancer Federal University of São Paulo Completed No outcome recorded
— NCT00126464 Nov 2004 → ? breast cancer Cedars-Sinai Medical Center Unknown No outcome recorded
Comparator or background therapy194 trials
Phase 0 NCT02913430 Comparator Apr 2018 → Apr 2022 breast cancer Shannon Puhalla Completed No outcome recorded
Phase 1 NCT06218303 Background Feb 2024 → Aug 2026 overdue ductal breast carcinoma in situ Finn, Olivera, PhD Recruiting No outcome recorded
Phase 1 NCT05755581 Comparator Apr 2023 → Apr 2025 breast cancer Sohag University Unknown No outcome recorded
Phase 1 NCT04504331 Background Oct 2020 → Oct 2021 Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, progesterone-receptor positive breast cancer Jennifer Lee Caswell-Jin Terminated No outcome recorded
Phase 1 NCT02936206 Comparator Oct 2016 → May 2020 breast cancer Icahn School of Medicine at Mount Sinai Terminated No outcome recorded Stop: Enrollment
Show all 194 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2017-12-06 Novartis Pharmaceuticals Results Kisqali® first and only CDK4/6 inhibitor to show superior efficacy vs. oral endocrine therapy as 1L treatment in randomized Phase III trial in premenopausal women with HR+/HER2- advanced breast cancer novartis.com ↗
Kisqali plus an oral endocrine partner demonstrated significant efficacy with sustained benefit of nearly two years (median PFS 23.8 vs 13.0 months for endocrine therapy alone) and an early response with separation of the PFS curves as early as eight weeks[1]
2003-02-21 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Final Approval of Tamoxifen Citrate Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has approved the company's ANDAs for Tamoxifen Citrate Tablets USP, 10 mg and 20 mg.
2000-06-01 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Pharmaceutical Industries Ltd Receives Final FDA Approval of Tamoxifen Citrate 10 mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that Pharmachemie B.V., its Dutch subsidiary, received US FDA final approval to manufacture and market Tamoxifen Citrate 10mg Tablets.

Evidence & citations 48 cited values

Every value below carries the sentence it was read from. 421 sources stand behind the page.

FieldValueCited text
Known as tamoxifen “Options include tamoxifen (20 mg daily), aromatase inhibitors (letrozole 2.5 mg daily, anastrozole 1 mg daily, or exemestane 25 mg daily), or fulvestrant (500 mg...” NCT07708194 ↗
401

“Endocrine therapy is determined by the doctor, including any kind of letrozole, anastrozole, exemestane, fulvestrant, tamoxifen, toremifene, combined with or without drugs or...” NCT03204734 ↗

“Pre- and peri-menopausal women will be receiving Ovarian Function Suppression (OFS) by either leuprorelin subcutaneous 3.75 mg q28days or goserelin subcutaneous 3.6 mg q28days...” NCT03969121 ↗

“Endocrine therapy (physician's choice based on prior administered agent including tamoxifen, exemestane, fulvestrant, anastrozole, or letrozole). Endocrine therapy must be...” NCT03184090 ↗

“Tamoxifen 20 mg daily, or letrozole 2.5 mg daily, or anastrozole 1 mg daily, or exemestane 25 mg daily (male patients will be treated with tamoxifen 20 mg daily) for a total...” NCT03081234 ↗

“Participants will receive standard of care mTOR inhibitor therapy (Everolimus) in combination with selective estrogen receptor modulator therapy (Tamoxifen) in Step 2 Arm 2 and Step 3.” NCT05826964 ↗

“Letrozole 2.5 mg by mouth daily, or anastrozole 1 mg by mouth daily, exemestane 25 mg by mouth daily, tamoxifen 20 mg by mouth daily, for a total duration of at least 60 months.” NCT03078751 ↗

“The physician's choice of endocrine therapy (PCET) is limited to tamoxifen or one of the specified third generation aromatase inhibitors: letrozole, anastrozole, or exemestane.” NCT04961996 ↗

“Endocrine therapy: letrozole (2.5mg daily), anastrozole (1mg daily), exemestane (25mg daily), tamoxifen (20mg daily) or fulvestrant (intramuscular 500mg every 4 weeks)” NCT06585969 ↗

“1-month GnRH (goserelin 3.6 mg depot or goserelin 3.6 mg implant or leuprolide 3.75 mg depot) +endocrine therapy (aromatase inhibitor/tamoxifen±CDK4/6 inhibition)” NCT07610733 ↗

“aromatase inhibitor (letrozole 2.5mg/d PO, anastrazole 1mg/d PO, or exemestane 25mg/d PO)or Selective Estrogen Receptor Modulator (SERM) (tamoxifen 20mg/d PO)” NCT00240071 ↗

Show 391 more sources

Known as ApoTamox “All participants will receive tamoxifen (ApoTamox) for approximately 6 months (6 months + 1 week).” NCT04915846 ↗
Known as Baby Tamoxifen “Randomized Double Blind Phase II Trial of Baby Exemestane vs Baby Tamoxifen in Post-menopausal Women at High Risk for Breast Cancer.” NCT06364267 ↗
Known as BabyTAM “The purpose of the study is to to compare low dose of exemestane (babyexe) versus low dose of tamoxifen (babytam) in terms of change of quality of life from baseline to 12 months.” NCT06364267 ↗
Known as Emblon ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as Fentamox 10 ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as Fentamox 20 ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as I.C.I.46474 CITRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as ICI 46,474 ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as ICI-47699 ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as Kentadex ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as Kessar ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as Kessar 10 ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as Kessar 20 ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as Mammaton ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as Noltam ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as Nolvadex “Tamoxifen (Nolvadex)” NCT07806630 ↗
1

“NOLVADEX (tamoxifen)” NCT00232661 ↗

Known as Nolvadex (tamoxifen) “Nolvadex (tamoxifen)” NCT00240071 ↗
1

“Nolvadex (tamoxifen)” NCT01897441 ↗

Known as Nolvadex d ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as Nolvadex fte ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as Nourytam ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as Novaldex ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as NSC-180973 “Arm I: Antiestrogen Therapy. Tamoxifen, TMX, NSC-180973.” NCT00929591 ↗
Known as NSC-727681 ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗
Known as NSC-757345 ChEMBL registry synonym — accepted as the source's own label CHEMBL83 ↗