Drugs / Hydroxocobalamin
Hydroxocobalamin
also known as
Hydroxycobalamin · vitamin B12 · Cyanokit · hydroxycobalamine · Trineurosol Hp · Vitamin B12 Depot · Vitamin B12a
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Cyanokit | — | 2007-11-23 | europa.eu ↗ |
| Approved | US (FDA) | ALPHAREDISOL | — | 1975-04-18 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07469189 | Jan → Jun 2023 | — | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03446599 | Nov 2019 → May 2020 | coronary artery disorder, heart valve disorder, hypotensive disorder | Dartmouth-Hitchcock Medical Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT03783091 | Aug 2019 → Feb 2023 | infectious disease with sepsis | Medical College of Wisconsin | Completed | No outcome recorded |
| Phase 2 | NCT03735316 | Apr 2019 → Apr 2022 | — | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05536596 | Sep 2022 → Jun 2024 | autosomal dominant prognathism | Universitat Internacional de Catalunya | Unknown | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07163364 | Aug 2025 → Oct 2026 expected | methylmalonic acidemia | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT01147289 | Feb → Nov 2011 | sciatica | Eurofarma Laboratorios S.A. | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04627181 | Nov 2020 → Mar 2021 | deficiency anemia, iron deficiency anemia | Christian Medical College, Vellore, India | Unknown | No outcome recorded |
| Phase 4 | NCT04054999 | Nov 2019 → Feb 2023 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT03372447 | Dec 2017 → Dec 2018 | pernicious anemia | Hospital Universitario Dr. Jose E. Gonzalez | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00479479 | Dec 2004 → Aug 2006 | vitamin B12 deficiency | Haukeland University Hospital | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT04259060 Comparator | Jan 2024 → Aug 2025 | ulcerative colitis | Joshua Korzenik | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT06160219 Comparator | Aug 2019 → Nov 2023 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT02270749 Comparator | Oct 2014 → Jun 2016 | vitamin B12 deficiency | Rijnstate Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01832129 Comparator | May 2013 → Dec 2015 | vitamin B12 deficiency | University Hospital, Basel, Switzerland | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-07-03 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - HIGH-CONCENTRATION HYDROXOCOBALAMIN HYDROCHLORIDE INJECTION OBTAINS CLINICAL TRIAL APPROVAL IN CHINA FOR THE TREATMENT OF METHYLMALONIC ACIDEMIA (MMA) irasia.com ↗
HIGH-CONCENTRATION HYDROXOCOBALAMIN HYDROCHLORIDE INJECTION OBTAINS CLINICAL TRIAL APPROVAL IN CHINA FOR THE TREATMENT OF METHYLMALONIC ACIDEMIA (MMA) |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-12 | Eli Lilly and Company | An open letter from Eli Lilly and Company warning of potential patient safety risks associated with tirzepatide compounded with vitamin B12 lilly.com ↗ |
| 2025-07-03 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - HIGH-CONCENTRATION HYDROXOCOBALAMIN HYDROCHLORIDE INJECTION OBTAINS CLINICAL TRIAL APPROVAL IN CHINA FOR THE TREATMENT OF METHYLMALONIC ACIDEMIA (MMA) irasia.com ↗ |
| 2010-04-01 | Sobi, Inc. | Swedish Orphan Biovitrum extends Cyanokit® cooperation with Merck Serono sobi.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Hydroxocobalamin | “Dexalgen® will be administered at a dose equivalent to dexamethasone 1.5 mg, dipyrone 500 mg, and hydroxocobalamin 5 mg (one ampoule for each type) a day at a single intramuscular dose” NCT01147289 ↗10“Group I-IM received four, weekly injections of 1000 µg hydroxocobalamin.” PMID 28421567 ↗ Apr 2017 |
| Known as | Cyanokit | “Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes” NCT04054999 ↗ |
| Known as | Hydroxycobalamin | “Drug: Hydroxycobalamin” NCT04627181 ↗ |
| Known as | hydroxycobalamine | “Single dose of hydroxycobalamine (Trineurosol Hp, Tridoss Laboratories, Mumbai, India) 1000 mcg administered intramuscularly in the deltoid of the non-fistula arm immediately...” NCT04627181 ↗ |
| Known as | Trineurosol Hp | “Single dose of hydroxycobalamine (Trineurosol Hp, Tridoss Laboratories, Mumbai, India) 1000 mcg administered intramuscularly in the deltoid of the non-fistula arm immediately...” NCT04627181 ↗ |
| Known as | vitamin B12 | “High-Dose IV Hydroxocobalamin (Vitamin B12) in Septic Shock: A Double-Blind, Allocation-Concealed, Placebo-Controlled Single-Center Pilot Randomized Controlled Trial (The...” PMID 36174744 ↗ Sep 20221“Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.” NCT05536596 ↗ |
| Known as | Vitamin B12 Depot | “an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)” NCT00479479 ↗ |
| Known as | Vitamin B12a | “Hydroxocobalamin drug, or Vitamin B12a, generally used to treat cyanide toxicity.” NCT07469189 ↗ |
| Route | Intramuscular | “an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)” NCT00479479 ↗ |