Drugs / Calcium carbonate
Calcium carbonate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | PEPCID COMPLETE | — | 2000-10-16 | fda.gov ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT06650930 | Jan → Aug 2025 overdue | pregnancy disorder | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT04620252 | Feb 2021 → Mar 2022 | dental caries | University of Michigan | Completed | No outcome recorded |
| Phase 19 trials | ||||||
| Phase 1 | NCT06882031 | Mar → Jun 2025 | acute promyelocytic leukemia | SDK Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06293326 | Mar → May 2024 | dyspepsia | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT06025773 | Sep 2023 → Apr 2024 | gastroesophageal reflux disease | Addpharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05109390 | Jul → Oct 2018 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02473367 | Jun → Aug 2015 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT04914936 | Sep → Oct 2014 | — | Acerta Pharma BV | Completed | No outcome recorded |
| Phase 1 | NCT01762995 | Dec 2012 → Mar 2013 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT00967629 | Jun 2009 → Feb 2010 | diabetic kidney disease | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 1 | NCT00682214 | May → Nov 2008 | vitamin D deficiency | Indian Council of Medical Research | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT00436475 | Sep 2007 → Nov 2009 | glucose intolerance, metabolic syndrome X, type 2 diabetes mellitus | Tufts Medical Center | Completed | Met primary |
| Phase 27 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT02916862 | Feb 2020 → Apr 2025 | osteoporosis | Florida International University | Completed | Missed primary |
| Phase 2 | NCT01994733 | Jan 2014 → Apr 2015 | end stage renal failure | Unity Health Toronto | Completed | No outcome recorded |
| Phase 2 | NCT01403051 | Sep 2011 → Feb 2013 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | Met primary |
| Phase 2 | NCT01037452 | Dec 2009 → Jan 2010 | dyspepsia | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00560300 | Nov 2000 → Nov 2006 | renal osteodystrophy | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 2 | NCT00000429 | Jun 1996 → May 2001 | juvenile idiopathic arthritis | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT00000426 | Jan 1995 → Jun 2000 | osteoporosis | Creighton University | Completed | No outcome recorded |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT07056062 | Apr 2024 → May 2025 | dystocia, uterine disorder | Arrowhead Regional Medical Center | Completed | No outcome recorded |
| Phase 2/3 | NCT00153816 | Jul 2004 → Oct 2013 | colon adenoma, colorectal cancer, polyp | Dartmouth-Hitchcock Medical Center | Completed | Missed primary |
| Phase 37 trials · 3 missed | ||||||
| Phase 3 | NCT00799383 | Nov 2008 → Mar 2014 | acquired hyperprolactinemia | Chadi A. Calarge | Completed | No outcome recorded |
| Phase 3 | NCT00486512 | Jun 2007 → Nov 2010 | adenomatous colon polyp | Colotech A/S | Terminated | Missed primary |
| Phase 3 | NCT00421343 | Feb 2007 → Jun 2008 | osteoporosis | Hebrew SeniorLife | Completed | No outcome recorded |
| Phase 3 | NCT00650637 | Jan → Aug 2003 | diarrheal disease | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00030238 | Feb 2002 → Dec 2007 | obesity disorder | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | Missed primary |
| Phase 3 | NCT00186901 | Jul 2000 → Jun 2009 | acute lymphoblastic leukemia, osteoporosis | St. Jude Children's Research Hospital | Completed | Missed primary |
| Phase 3 | NCT00398606 | Apr 1995 → Feb 1998 | postmenopausal osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 44 trials · 1 missed | ||||||
| Phase 4 | NCT06580782 | Nov 2024 → Dec 2025 overdue | dystocia | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 4 | NCT04258475 | Dec 2020 → Jun 2024 | — | Ottawa Hospital Research Institute | Unknown | No outcome recorded |
| Phase 4 | NCT01748396 | Jul 2012 → Jan 2013 | chronic kidney disease | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01447433 | Apr 2011 → Jan 2012 | obesity disorder | Changhai Hospital | Completed | Missed primary |
| Phase not applicable4 trials | ||||||
| — | NCT06464718 | Jun → Dec 2022 | — | Frontier Medical and Dental College, Abbotabad | Completed | No outcome recorded |
| — | NCT03550534 | Nov 2015 → Dec 2016 | chronic kidney disease | Indonesia University | Completed | No outcome recorded |
| — | NCT01107808 | Jun 2009 → Sep 2010 | obesity disorder, vitamin D deficiency | University of Alabama at Birmingham | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00302627 | Jan 1999 → Nov 2002 | disease related to transplantation | Providence Health & Services | Completed | No outcome recorded |
| Comparator or background therapy54 trials | ||||||
| Phase 1 | NCT03612466 Background | Aug 2022 → Jan 2023 | bone neoplasm, osteosarcoma | Albert Einstein College of Medicine | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02647671 Comparator | Apr 2016 → Mar 2021 | colorectal cancer | James Varani | Completed | No outcome recorded |
| Phase 1/2 | NCT01375010 Background | Jan 2011 → Feb 2016 | HIV infectious disease | Columbia University | Completed | No outcome recorded |
| Phase 2 | NCT06503978 Background | Aug 2024 → Jul 2025 overdue | autism spectrum disorder, constipation disorder, diarrheal disease | Gut-Brain-Axis Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06321796 Background | Feb 2024 → Feb 2025 | Pitt-Hopkins syndrome | Gut-Brain-Axis Therapeutics Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT01696279 Comparator | Feb 2013 → Nov 2018 | chronic kidney disease, hyperphosphatemia | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01739855 Comparator | Nov 2012 → Jul 2014 | — | Medical University of Vienna | Completed | No outcome recorded |
| Phase 2 | NCT01867697 Background | May 2012 → Mar 2019 | colorectal cancer | Per Pfeiffer | Completed | No outcome recorded |
| Phase 2 | NCT01493050 Comparator | Feb 2012 → Dec 2013 | diabetic kidney disease | Gary Striker | Completed | No outcome recorded |
| Phase 2 | NCT00996801 Background | Nov 2009 → Jun 2011 | postmenopausal osteoporosis | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 2 | NCT00074711 Comparator | Aug 2004 → Jun 2008 | osteoporosis | Creighton University | Completed | No outcome recorded |
| Phase 2 | NCT00004488 Background | Oct 1998 → Sep 2002 | Gaucher disease, osteoporosis | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT00001304 Background | Oct 1991 → Mar 2014 | hypoparathyroidism | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 2 | NCT00061256 Background | ? → Sep 2006 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/3 | NCT03824587 Background | Feb → Jul 2019 | hyperphosphatemia | Ardelyx | Completed | Met primary |
| Phase 3 | NCT05305183 Background | May 2022 → May 2023 | osteoporosis | Shandong New Time Pharmaceutical Co., LTD | Unknown | No outcome recorded |
| Phase 3 | NCT03634917 Comparator | Aug 2020 → Aug 2023 | alcohol dependence | Technical University Dresden | Completed | No outcome recorded |
| Phase 3 | NCT03930992 Comparator | Apr 2019 → Oct 2022 | osteoporosis | University of Guadalajara | Completed | No outcome recorded |
| Phase 3 | NCT02186600 Background | Feb 2015 → Jun 2019 | — | University of Nebraska | Completed | Missed primary |
| Phase 3 | NCT01578200 Comparator | Dec 2011 → Mar 2019 | hyperphosphatemia | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Completed | Missed primary |
| Phase 3 | NCT01190683 Comparator | Aug 2010 → Apr 2011 | vitamin D deficiency | Indian Council of Medical Research | Completed | No outcome recorded |
| Phase 3 | NCT00507000 Background | May 2008 → Sep 2010 | tuberculosis | Indian Council of Medical Research | Unknown | No outcome recorded |
| Phase 3 | NCT01514851 Comparator | Jan → May 2006 | hyperphosphatemia | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00352846 Background | Jan 2006 → Sep 2011 | non-Hodgkin lymphoma | M.D. Anderson Cancer Center | Completed | Met primary |
| Phase 4 | NCT06385093 Comparator | Jun 2024 → Dec 2025 | osteoporosis, rheumatoid arthritis | Chinese SLE Treatment And Research Group | Unknown | No outcome recorded |
| Phase 4 | NCT06660524 Comparator | Mar 2024 → Jun 2025 overdue | cardiac valvular defect, chronic kidney disease, heart valve disorder, mineral metabolism disease | China National Center for Cardiovascular Diseases | Recruiting | No outcome recorded |
| Phase 4 | NCT06042985 Comparator | Dec 2023 → Apr 2024 | — | General Committee of Teaching Hospitals and Institutes, Egypt | Unknown | No outcome recorded |
| Phase 4 | NCT05577507 Comparator | Mar → May 2023 | chronic kidney disease, hyperphosphatemia | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT05313477 Comparator | May 2022 → Aug 2023 | chronic hepatitis B virus infection, vitamin D deficiency | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT02393482 Comparator | Jun → Dec 2021 | amenorrhea, endometriosis | University of Cagliari | Unknown | No outcome recorded |
| Phase 4 | NCT03425747 Comparator | Oct 2019 → Apr 2020 | hypoparathyroidism | Campus-Bio-Medico University | Completed | No outcome recorded |
| Phase 4 | NCT04618952 Comparator | Jan 2019 → Aug 2020 | hypertensive disorder | Shiraz University of Medical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT02836184 Comparator | Jul → Sep 2016 | hyperphosphatemia | Jiujiang No.1 People's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02237534 Comparator | Sep 2014 → Mar 2023 | chronic kidney disease, hyperphosphatemia, metabolic bone disorder | Osaka University | Unknown | No outcome recorded |
| Phase 4 | NCT02031692 Comparator | Dec 2013 → May 2017 | benign paroxysmal positional vertigo | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04609189 Comparator | Jul 2012 → May 2014 | postmenopausal osteoporosis | University of Alberta | Completed | No outcome recorded |
| Phase 4 | NCT01845090 Comparator | Aug 2011 → Jul 2014 | — | Camillians Saint Mary's Hospital Luodong | Unknown | No outcome recorded |
| Phase 4 | NCT02620345 Background | Jan 2010 → Oct 2015 | benign neoplasm of corpus uteri | Trieu, Nguyen Thi, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT01755078 Comparator | Jun 2007 → Jun 2009 | hyperphosphatemia | Chugai Pharma Taiwan | Completed | No outcome recorded |
| — | NCT07597096 Comparator | May → Jun 2026 overdue | secondary hypoparathyroidism due to impaired parathormon secretion | King Edward Medical University | Not yet recruiting | No outcome recorded |
| — | NCT07577570 Comparator | Nov 2025 → Oct 2027 expected | hypoparathyroidism | Tartu University Hospital | Recruiting | No outcome recorded |
| — | NCT05252884 Comparator | Jun 2022 → Oct 2024 | goiter, hyperthyroidism, thyroid cancer, thyroiditis | Centro de Excelencia en Enfermedades de Cabeza y Cuello | Completed | No outcome recorded |
| — | NCT06218212 Comparator | Feb 2022 → Mar 2023 | acute kidney injury | Ain Shams University | Completed | No outcome recorded |
| — | NCT05559619 Comparator | Jul 2021 → Jun 2022 | postmenopausal osteoporosis | Cairo University | Completed | No outcome recorded |
| — | NCT02827643 Comparator | Jun 2016 → Mar 2017 | bone disorder | Mahidol University | Unknown | No outcome recorded |
| — | NCT03484416 Comparator | Mar 2016 → May 2017 | thyroid cancer | Ewha Womans University Mokdong Hospital | Completed | No outcome recorded |
| — | NCT02273570 Background | Mar 2015 → Dec 2016 | secondary hyperparathyroidism of renal origin | Azienda Ospedaliera Sant'Anna | Unknown | No outcome recorded |
| — | NCT02922803 Comparator | May 2010 → Aug 2016 | myopathy, vitamin D deficiency | Uppsala University | Completed | No outcome recorded |
| — | NCT00837655 Comparator | Jan 2009 → Jun 2011 | chronic renal failure syndrome, end stage renal failure, hyperphosphatemia | Karolinska Institutet | Withdrawn | No outcome recorded |
| — | NCT00982722 Background | Apr 2008 → May 2018 | primary hyperparathyroidism | Karolinska University Hospital | Completed | No outcome recorded |
| — | NCT00710788 Comparator | Jan 2007 → Sep 2010 | — | Azienda Sanitaria ASL Avellino 2 | Completed | No outcome recorded |
| — | NCT00736632 Background | May 2006 → Jan 2019 | hypertensive disorder, type 2 diabetes mellitus, vitamin D deficiency | Washington University School of Medicine | Completed | No outcome recorded |
| — | NCT01049815 Comparator | Feb 2005 → Feb 2009 | end stage renal failure | Tel-Aviv Sourasky Medical Center | Completed | No outcome recorded |
| — | NCT00004489 Background | Oct 1998 → Sep 2002 | cystic fibrosis, osteoporosis | University of North Carolina | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2015-10-26 | Lupin Limited | Regulatory Lupin Launches Generic PhosLo® in the US lupin.com ↗
Mumbai: Pharma Major Lupin Limited announced today that its US subsidiary, Lupin Pharmaceuticals Inc. (collectively Lupin) has launched its Calcium Acetate Capsules, 667 mg (eq. 169 mg Calcium) having received final approval from the United States Food and Drug Administration (FDA). |
| 2012-06-06 | Perrigo Company | Regulatory Perrigo Receives FDA Approval for Calcium Acetate Capsules perrigo.com ↗
Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for calcium acetate capsules, the generic equivalent of Phoslo® Gelcaps. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-10-26 | Lupin Limited | Lupin Launches Generic PhosLo® in the US lupin.com ↗ |
| 2012-06-06 | Perrigo Company | Perrigo Receives FDA Approval for Calcium Acetate Capsules perrigo.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 90 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Calcium carbonate | “Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg...” NCT01375010 ↗90“The patient will receive a dose of 1,200 mg Calcium carbonate every 8 hours + 0.25 mcg of calcitriol every 12 hours orally for 15 days, starting on the same day as the intervention.” NCT05252884 ↗ “Once daily calcium carbonate 1,250 mg that equal to elemental calcium 600 mg and weekly vitamin D2 20,000international units are given in intervention arms for duration of 24 weeks” NCT02827643 ↗ “If some participants cannot tolerate the aluminum/magnesium hydroxide, we will allow calcium carbonate alternatives equivalent in acid neutralizing capacity.” NCT06321796 ↗ “We will give women in one group a placebo (inactive pill) and women in the other group 1500 milligrams of calcium per day (as calcium carbonate).” NCT00000426 ↗ “60,000 IU sachet and calcium carbonate Oral cholecalciferol (vitamin D)60,000 IU weekly along with daily oral dose of 1 gm calcium carbonate” NCT00507000 ↗ “Each tablet contained 500 milligrams of calcium carbonate and 200 international units (IU) of vitamin D3(cholecalciferol).” NCT04618952 ↗ “supplementation with 1250 mg calcium carbonate and 400 IU of vitamin D3 in risperidone-induced hyperprolactinemia.” PMID 29112461 ↗ Nov 2017 “calcium compound containing 25 g calcium carbonate (500mg elemental calcium) and vitamin D3 400IU taken daily” NCT06464718 ↗ “calcium carbonate antacid as TUMS® Ultra Strength (US) 1000 and 1200 mg raltegravir given concomitantly” PMID 27671833 ↗ Sep 2016 “2 Arm (HIV+): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)” NCT03930992 ↗ |
| Known as | BAY1180654 | “bi-layer calcium carbonate tablet (BAY1180654)” NCT06293326 ↗ |
| Known as | CaC03 | “The active treatment group is taking, in a single daily dose, two 500 mg tablets of elemental Ca as CaC03 (calcium carbonate) and one multivitamin tablet containing 400 IU vitamin D.” NCT00000429 ↗ |
| Known as | CaCO3 | “Daily dose of 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol, Rocaltrol; Roche, Basel, Switzerland), 75 mg acetylsalicylic acid (ASA), and 1250 mg calcium carbonate (CaCO3).” NCT00486512 ↗ |
| Known as | Kalcidon | “Calcium carbonate tablets, 250 mg (Kalcidon, Abigo AB).” NCT00837655 ↗ |
| Known as | Tums | “calcium carbonate (commonly marketed as "Tums")” NCT06650930 ↗1“Calcium carbonate (Tums), vitamin D” NCT00186901 ↗ |
| Known as | Tums tablets | “1,000 mg of calcium carbonate (Tums tablets) by mouth” NCT00000429 ↗ |
| Modality | Other / unclassified | “Calcium-based phosphate binders can induce hypercalcaemia and are associated with progression of vascular calcification.” NCT01578200 ↗ |
| Route | Oral | “1,000 mg of calcium carbonate (Tums tablets) by mouth” NCT00000429 ↗ |