Delving into the Latest Updates on Hydroxocobalamin with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

HXC, Hydroxocobalamin (JAN/USP/INN), Hydroxocobalamin anhydrous

+ [14]

Target

IFNAR

Action

agonists

Mechanism

IFNAR agonists(Interferon alpha/beta receptor agonists)

Therapeutic Areas

Nervous System DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [5]

Active Indication

Cyanide poisoningAmblyopiaOptic Atrophy, Hereditary, Leber+ [6]

Inactive Indication-

Originator Organization

Merck & Co., Inc.

Active Organization

Anyang Jiuzhou Pharmaceutical Co. Ltd.

China Resources Double-Crane Pharmaceutical Co., Ltd.SERB SA

+ [5]

Inactive Organization

Actavis

Merck & Co., Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (18 Apr 1975),

Poisoning

RegulationOrphan Drug (United States)

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Structure/Sequence

Molecular FormulaC62H89CoN13O15P

InChIKeyXVXCLEXSDVMESA-UHFFFAOYSA-L

CAS Registry13422-51-0

The bilateral sagittal split osteotomy (BSSO) of the mandible is one of the most used surgical techniques to achieve a harmonious jaw relation in the context of orthognathic surgery. Nevertheless, one of its main complications is neurosensory damage to the inferior alveolar nerve, which can cause severe impact in the quality of life on patients who suffer from it permanently. The purpose of this randomized clinical trial is to provide rigorous scientific evidence of the pharmacological effect of 1) Melatonin, 2) combination uridine triphosphate (UTP), cytidine monophosphate (CMP), and hydroxycobalamin (UTP/CMP/hydroxycobalamin) and 3) hydroxycobalamin regarding neurosensory disturbances incidence and persistence after BSSO.

Start Date30 Sep 2022

Sponsor / Collaborator

Universitat Internacional de Catalunya

[+1]

IRCT20211207053311N1

/ RecruitingPhase 3IIT

Evaluation of response rate to hydroxycobalamin treatment in patients with methylmalonic acidemia

Start Date04 Feb 2022

Sponsor / Collaborator

Mashhad University of Medical Sciences

PER-040-21

Phase 3

CLINICAL TRIAL, DOUBLE-BLIND, RANDOMIZED, COMPARED WITH PLACEBO TO EVALUATE THE EFFICACY AND SAFETY OF HYDROXOCOBALAMIN (VITAMIN B12) 10,000 MCG + THIAMINE HYDROCHLORIDE (VITAMIN B1) 100 MG + PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) 50 MG (BEDOYECTA® TRI), COMBINATED WITH STANDARD OF CARE TREATMENT IN PATIENTS WITH CHRONIC LOW BACK PAIN.

Start Date02 Aug 2021

Sponsor / Collaborator-

100 Clinical Results associated with Hydroxocobalamin

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100 Translational Medicine associated with Hydroxocobalamin

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100 Patents (Medical) associated with Hydroxocobalamin

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1,560

Literatures (Medical) associated with Hydroxocobalamin

01 Aug 2025·JHLT Open

Prognostic value of the vasoactive-inotropic score in predicting outcomes following LVAD implantation

Article

Author: Ogbue, Patrick ; Rusia, Akash ; Michael DiMaio, J ; Kabra, Nitin ; Dorton, Cody W ; George, Timothy J ; Rawitscher, David A ; Afzal, Aasim ; Pickering, Taylor ; McCullough, Kyle A ; Milligan, Greg

Background:

Vasoplegia frequently complicates left ventricular assist device (LVAD) implantation, yet its impact on outcomes is not fully understood. The vasoactive-inotropic score (VIS), which quantifies vasoactive support, may predict outcomes in this population.

Methods:

A retrospective analysis of 146 patients undergoing HeartMate 3 LVAD implantation from 2017 to 2024 at a single institution was performed. VIS was calculated at 0, 6, 12, and 24 hours postoperatively, and the maximum VIS(VIS_max) within the first 24 hours was determined: VIS = dopamine (mcg/kg/min) + dobutamine (mcg/kg/min) + 100*epinephrine (mcg/kg/min) + 10*milrinone (mcg/kg/min) + 10,000*vasopressin (units/kg/min) + 100*norepinephrine (mcg/kg/min). Patients were stratified by VISmax tertiles, and survival outcomes were compared using Kaplan-Meier estimates and Cox proportional hazards modeling. Secondary outcomes included predictors of vasodilation and postoperative complications.

Results:

The mean VIS_max was 18.2 ± 10.1. Patients in the highest VIS_max tertile (20-56) demonstrated lower 1-year survival (67.0% vs 84.3% vs 90.0%, p < 0.01). Preoperative Impella support (p = 0.02), elevated bilirubin (p < 0.01), and longer cardiopulmonary bypass time (p < 0.01) were predictors of increased VIS_max. VIS_max was an independent predictor of 1-year mortality (HR: 1.08[1.04-1.12], p < 0.01) and associated with increased odds of right ventricular assist device placement, renal replacement therapy, and tracheostomy (all p < 0.01). Hydroxocobalamin pre-treatment was associated with lower VIS_max (15.65 ± 9.52 vs 19.40 ± 10.25, p = 0.04).

Conclusion:

Elevated VIS_max is a predictor of morbidity and mortality following LVAD implantation. Strategies such as preoperative hydroxocobalamin administration may mitigate postoperative vasoplegia. Further studies are warranted to refine risk stratification and optimize management for these high-risk patients.

01 Aug 2025·Current Opinion in Critical Care

Biologic rationale and evidence for high-dose hydroxocobalamin in septic shock

Review

Author: Patel, Jayshil J. ; Willoughby, Rodney ; Carr, Jason

Purposes of review:

The inflammatory response in sepsis raises circulatory levels of gaseous transmitters (gasotransmitters) nitric oxide (NO) and hydrogen sulfide (H2S), both of which generate and sustain septic shock. Current best practices, including early intravenous fluid, early antibiotics, and vasopressor support, do not target gasotransmitters. A single 5-g dose of intravenous hydroxocobalamin (high-dose HOC) is a safe intervention that targets circulating gasotransmitters. In this review, we provide an overview of the role of gasotransmitters in septic shock, outline the rationale for high-dose HOC in septic shock, and summarize clinical evidence for high-dose HOC in septic shock.

Recent findings:

NO and H2S are elevated early in septic shock, activate inflammatory pathways, and higher levels correlate with greater severity of illness. Preclinical evidence demonstrates high-dose HOC improves outcomes in models of septic shock by scavenging circulating NO and H2S. Multiple case series and a Phase IIa trial show that high-dose HOC is a safe intervention that reduces vasopressor dose in adults with septic shock. Without high-level evidence, clinicians across the United States are using high-dose HOC for adults with septic shock.

Summary:

High-dose HOC is a promising, nontoxic intervention that targets the pathophysiologic pathway of septic shock. Despite compelling observational and Phase IIa trial data, a pivotal phase III trial testing high-dose HOC in adults with septic shock is required before widespread use can be recommended.

08 Jul 2025·BRITISH JOURNAL OF ANAESTHESIA

Hydroxocobalamin for vasoplegia in cardiac surgery: a retrospective cohort analysis.

Article

Author: Alfirevic, Andrej ; Skubas, Nikolaos J ; Sessler, Daniel I ; Hohlfelder, Benjamin ; Elgharably, Haytham ; Yang, Dongsheng ; Ahuja, Sanchit ; Kelava, Marta ; Khanna, Ashish K ; Shah, Karan ; Zakaria, Luai ; Duncan, Andra E

BACKGROUND:

Vasoplegia during cardiac surgery is common and associated with perioperative mortality. Hydroxocobalamin is a catecholamine-sparing approach for treating vasoplegia. However, there is currently limited evidence to inform its use.

METHODS:

We conducted a single-centre retrospective propensity-matched cohort study of patients who developed vasoplegia after cardiopulmonary bypass. Our primary outcome was vasopressor requirement, expressed as norepinephrine equivalents (NEE), at 1, 4, 24, and 48 h after treatment. Our secondary outcome was a collapsed composite of in-hospital complications comprising stroke, sternal wound infection, mesenteric ischaemia, renal failure, and death.

RESULTS:

We identified 2727 (11%) patients with vasoplegia from 2018 to 2024. The final analysis cohort included 229 matched pairs. Hydroxocobalamin administration was associated with a significant reduction in median NEE infusion rates of -0.04 (95% confidence interval [CI]: -0.07 to -0.02; P=0.008) μg kg^-1 min^-1 at 1 h, -0.05 (95% CI: -0.07 to -0.02; P<0.001) μg kg^-1 min^-1 at 4 h, and -0.04 (95% CI: -0.06 to -0.02; P=0.004) μg kg^-1 min^-1 at 24 h, but not at 48 h, -0.02 (95% CI: -0.05 to 0.0; P=0.220) μg kg^-1 min^-1. Over the initial 24 h, hydroxocobalamin reduced NEE by 14% compared with the reference group. The risk of in-hospital complications was similar in each group (odds ratio: 1.06; 95% CI: 0.74-1.54; P=0.745).

CONCLUSIONS:

Hydroxocobalamin administration was associated with reduced vasopressor requirement over 24 h, but not thereafter. Robust trials are needed to determine whether this relationship is causal, and whether a reduction in vasopressor use improves substantive clinical outcomes.

1

News (Medical) associated with Hydroxocobalamin

12 Jul 2021

·www.pharmaindustrial-india.com

NPPA seeks PTR & MAT value for 29 formulations from drug manufacturers & marketers to fix ceiling prices

The National Pharmaceutical Pricing Authority (NPPA) has asked drug manufacturers and marketers to furnish the information relating to price to retailer (PTR) and moving annual turnover (MAT) in value term for about 29 NLEM formulations for the month of March 2021. The information will be used by NPPA for fixing ceiling price of the formulations under provisions of DPCO, 2013. The formulations include abacavir (60mg tablet), acetylsalicylic acid (effervescent/dispersible/enteric coated 300 mg to 500 mg tablet), acetylsalicylic acid (300 mg to 500 mg tablet), activated charcoal (powder as licensed), calcium carbonate (250 mg tablet), calcium folinate (3mg/ml injection), cloxacillin (125 mg/5 ml oral liquid), cycloserine (125 mg capsule), dapsone (50 mg tablet) and doxycycline (50 mg/ 5 ml dry syrup). The other formulations are ethionamide (125 mg tablet), ferrous salt (A) + folic acid (B) (20 mg elemental iron (A) + 100 mcg oral liquid), ferrous salts (tablet equivalent to 60 mg of elemental iron), hydroxocobalamin (1 mg/ml injection), iohexol (140 to 350 mg iodine/ml injection), lamivudine (A)+ zidovudine (B) ((30 mg (A)+60 mg (B) tablet), medroxyprogesterone acetate (5 mg tablet), methylthioninium chloride (methylene blue) (10 mg/ml injection), miltefosine (50 mg capsule) and nevirapine (50 mg dispersible tablet). Besides them, the list of formulations which will be placed under price control include nystatin (100,000 IU pessary) & nystatin (100,000 IU/ml oral liquid), paromomycin (375 mg/ml injection), povidone iodine (5 per cent drops), pyridoxine (50 mg tablet), sodium chloride (3 per cent injection), vitamin A (100000 IU/ml oral liquid) zidovudine (50 mg/ 5 ml oral liquid) and zidovudine (A)+ lamivudine (B)+ nevirapine (C) ((60 mg (A) + 30 mg (B) + 50 mg (C) tablet). Earlier NPPA had withdrawn ferrous salt (A) + folic acid (B) (20 mg elemental iron (A) + 100 mcg oral liquid) formulation from price control order. Rashmi Tahiliani, joint director (pricing), NPPA issued an office memorandum in this regard on July 9, 2021. Tahiliani asked the drug manufacturers and marketing firms to furnish the information pertaining to the formulations, their dosage form and strength, brand, pack size, MAT and PTR as on March 2021 in a prescribed format within ten days from the issue of this memorandum. The NPPA has also directed pharmaceutical organizations-- OPPI, IDMA, AISSPMA, FICCI, IPA and FOPE to ask their member companies to furnish the said information to it.

Drug ApprovalNucleic Acid DrugNDA

100 Deals associated with Hydroxocobalamin

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External Link

KEGG	Wiki	ATC	Drug Bank
D01027	Hydroxocobalamin	V03AB33 B03BA03	DB00200

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cyanide poisoning	United States	BTG International, Inc.	15 Dec 2006
Amblyopia	Australia	Pfizer Australia Pty Ltd.	26 Jun 2006
Optic Atrophy, Hereditary, Leber	Australia	Pfizer Australia Pty Ltd.	26 Jun 2006
Anemia, Megaloblastic	China	Anyang Jiuzhou Pharmaceutical Co. Ltd.	01 Jan 1996
Anemia, Megaloblastic	China	China Resources Double-Crane Pharmaceutical Co., Ltd.	01 Jan 1996
Anemia, Pernicious	China	China Resources Double-Crane Pharmaceutical Co., Ltd.	01 Jan 1996
Anemia, Pernicious	China	Anyang Jiuzhou Pharmaceutical Co. Ltd.	01 Jan 1996
Neuralgia	China	Anyang Jiuzhou Pharmaceutical Co. Ltd.	01 Jan 1996
Neuralgia	China	China Resources Double-Crane Pharmaceutical Co., Ltd.	01 Jan 1996
Vitamin B 12 Deficiency	China	Anyang Jiuzhou Pharmaceutical Co. Ltd.	01 Jan 1996
Vitamin B 12 Deficiency	China	China Resources Double-Crane Pharmaceutical Co., Ltd.	01 Jan 1996
Poisoning	United States	Merck & Co., Inc.	18 Apr 1975

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Methylmalonic Acidemia With Homocystinuria	Phase 3	China	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	12 Aug 2025
Methylmalonic Acidemia	Preclinical	United States	National Institutes of Health	09 Oct 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03735316 (CTgov)	Phase 2	Vasoplegia \| Hypotension	8	Cardiopulmonary Bypass+Hydroxocobalamin (B12a)	jclewdyaew(ujimvpmumw) = ygfdsjxjvu tsvvzkptoh (lttpgqeqxr, lzzjgvhwgl - clporlmotu) View more	-	10 May 2023
				Cardiopulmonary Bypass (Placebo)	jclewdyaew(ujimvpmumw) = rmyurhtkfe tsvvzkptoh (lttpgqeqxr, sdfwxpqxec - wektirszql) View more
NCT03783091 (IV-HOCSS Trial, Pubmed)	Phase 2	Shock, Septic	-	IV-HOC	ezdphxxvvl(ghmifltcdt) = kkiiqgqynv udvqbsvczl (gzvpoktuxr ) View more	Positive	26 Sep 2022
				Placebo	ezdphxxvvl(ghmifltcdt) = onlwqcddit udvqbsvczl (gzvpoktuxr ) View more