Delving into the Latest Updates on Tenofovir amibufenamide with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Hengmu, 艾美酚胺替诺福韦

+ [4]

Target

RT

Mechanism

RT inhibitors(Reverse transcriptase inhibitors)

Therapeutic Areas

Infectious DiseasesDigestive System DisordersImmune System Diseases+ [1]

Active Indication

Hepatitis B, ChronicHIV Infections

Inactive Indication-

Originator Organization

Jiangsu Hansoh Pharmaceutical Co. Ltd.

Active Organization

Jiangsu Hansoh Pharmaceutical Co. Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (24 Jun 2021),

Hepatitis B, Chronic

RegulationSpecial Review Project (CN), Priority Review (CN)

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Structure

Molecular FormulaC22H31N6O5P

InChIKeyORHSFGJQGPUCRR-RZCFMFBHSA-N

CAS Registry1571076-26-0

View All Structures (2)

The goal of this observational study is to explore the efficacy and safety of Tenofovir Amibufenamide (TMF) in Entecavir (ETV) treated chronic hepatitis B patients with low-level viraemia. The main question it aims to answer is:
The efficacy and safety of TMF in chronic hepatitis B patients with low-level viraemia.
What is the appropriate treatment for ETV treated chronic hepatitis B patients with low-level viraemia.
Participants will choose to maintain their original regimen (ETV) or switch to TMF After being fully informed of the benefits and risks of treatment.
Researchers will compare ETV and TMF to see if there is a difference in the efficacy of the two drugs in chronic hepatitis B patients with low-level viraemia.

Start Date01 Mar 2023

Sponsor / Collaborator

The Second Affiliated Hospital of Chongqing Medical University

[+1]

NCT05937178 / RecruitingNot ApplicableIIT

A Real-world Study of Optimizing Nucleotide-analogues-based Treatment for Chronic Hepatitis B

The goal of this multicenter, observational, prospective study is to observe and compare different anti-viral treatment strategies in a real-world cohort of patients with CHB managed in routine clinical settings in China. The main questions it aims to answer are:
To evaluate the benefits of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who are recommended in the updated Chinese Guideline 2022, but not recommended in the Chinese Guideline 2019.
To evaluate the Chinese Guideline recommends initiation of treatment, but at least one foreign authoritative guideline (eg. AASLD, EASL) does not recommend the benefit of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who initiate treatment.
To compare the treatment effect of different alternatives with patients who have partial response after treatment with first-line nucleos(t)ide analogues.

Start Date31 Jan 2023

Sponsor / Collaborator

Shanghai Huashan Hospital

[+38]

ChiCTR2200064306 / SuspendedPhase 4IIT

Efficacy and safety of long-term treatment with tenofovir amibufenamide in patients aged 65 years and over with chronic hepatitis B

Start Date01 Oct 2022

Sponsor / Collaborator-

100 Clinical Results associated with Tenofovir amibufenamide

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100 Translational Medicine associated with Tenofovir amibufenamide

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100 Patents (Medical) associated with Tenofovir amibufenamide

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10

Literatures (Medical) associated with Tenofovir amibufenamide

01 Mar 2024·International Journal of Pharmaceutics

Uncovering the mechanism of Tenofovir amibufenamide fumarate punch sticking by combining direct compression experiment and computational simulation

Article

Author: Gong, Junbo ; Zhang, Jin ; Wu, Songgu ; Chen, Weiqi ; Zhao, Chenyang ; Wang, Xiaolei ; Liu, Yanbo ; Qin, Xueyou

Punch sticking during tablet manufacturing is a prevalent issue for many active pharmaceutical ingredients (APIs) encountered by the pharmaceutical industry. Tenofovir amibufenamide fumarate (TMF), a heavyweight drug for the treatment of hepatitis B, was selected as a model drug due to its tendency to punch sticking during tablet compression. In this study, the cause of sticking was explored by investigating crystal habits, excipients and structure characteristics. The difference in sticking of three crystal habits can be visually represented through direct compression experiments on powdered samples and analysis of crystal surfaces. The excipients play a direct role in decreasing the probability of sticking, and the extent of sticking can be assessed by measuring the tensile strength of the tablet. Additionally, the plasticity index was utilized to theoretically analyze the potential enhancements of four excipients. These experimental results indicate that the block-shaped crystals have superior ability of anti-sticking and that suitable excipients can significantly improve the sticking situation of TMF. Ultimately, the phenomenon of punch sticking was additionally examined through computational calculations, focusing on the mechanical characteristics of TMF molecules and intermolecular interactions. The strategy of combining experiments and simulation calculations has broader significance for the study of drug production.

01 Sep 2023·Current opinion in nephrology and hypertension

Medication safety in chronic kidney disease.

Review

Author: Singh, Sonal

PURPOSE OF REVIEWSeveral drugs cause nephrotoxicity and accelerate progression of chronic kidney disease (CKD). The objective of this review is to summarize recent evidence on drugs that either increase the risk of nephrotoxicity, progression of CKD or drug induced harm in patients with CKD.RECENT FINDINGSBisphosphonates and hypnotics increase the progression of CKD, whereas denosumab does not accelerate progression of CKD. Tenofovir disoproxil fumarate (TDF) increases the risk of renal tubular toxicity and adverse effects on bone, but Tenofovir alafenamide (TAF) and Tenofovir amibufenamide (TMF) have favorable safety profile on the kidneys and bones. Although no dosage adjustment is needed for Oral Nirmatrelvir/Ritonavir in patients with mild renal impairment and coronavirus disease 2019, the dosage is reduced to twice daily in those with moderate renal impairment. It is not recommended in patients with severe renal impairment. The prescribing information does not recommend use of remdesevir below glomerular filtration rate (eGFR) < 30 ml/min but recent studies suggest that remdesevir may be safe and effective in patients with varying levels of CKD severity. Molnupiravir does not require dose adjustment in patients with CKD.SUMMARYSeveral medications increase the risk of development of acute kidney injury or progression of CKD. Close attention is needed to select the appropriate dose or safer alternatives to reduce the risk of drug-induced harm in patients with CKD.

20 Mar 2023·Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology

[Clinical efficacy analysis of TMF for the treatment of hyperviremia HBeAg-positive chronic hepatitis B patients with incomplete response to first-line oral antiviral nucleos(t)ide analogues].

Article

Author: Zhang, C ; Dou, X G ; Han, C ; Ding, Y ; Sheng, Q J ; Li, Y W

Objective: To prospectively explore the treatment strategies for clinical difficulties in patients with hyperviremia HBeAg-positive chronic hepatitis B with incomplete response to first-line nucleos(t)ide analogues (NAs). Methods: Patients with hyperviremia HBeAg-positive chronic hepatitis B were treated with first-line NAs, including entecavir, tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF) for 48 weeks or more. Tenofovir amibufenamide (TMF) or TAF therapy was changed when HBV DNA remained positive and then divided into a TMF group and a TAF group. Clinical efficacy of treatment was evaluated at 24 and 48 weeks, including HBV DNA undetectable rates and virological and serological responses in both patient groups. Results: In the TMF group and the TAF groups, 30 and 26 cases completed 24-week follow-up, while 18 and 12 cases completed 48-week follow-up. There were no statistically significant differences in baseline HBV DNA, HBsAg, and HBeAg levels between the two groups before switching to TMF/TAF therapy (P > 0.05). At 24 weeks of treatment, 19 (19/30, 63.33%) cases in the TMF group had HBV DNA negative conversion, while 14 (14/26, 53.85%) cases in the TAF group had HBV DNA negative conversion (P > 0.05). Among the patients who completed 48 weeks of follow-up, 15 (15/18, 83.33%) cases in the TMF group and 7 (7/12, 58.33%) cases in the TAF group had negative HBV DNA tests (P > 0.05). The changes in HBsAg and HBeAg levels between the two groups of patients at 24 and 48 weeks of treatment were not statistically significant compared to baseline (P > 0.05). Conclusion: TMF is effective in treating patients with hyperviremia HBeAg-positive CHB with an incomplete response to first-line NAs treatment, but there is no significant difference compared to TAF.

100 Deals associated with Tenofovir amibufenamide

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J05AF13 J05AF07	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis B, Chronic	CN	Jiangsu Hansoh Pharmaceutical Co. Ltd.	24 Jun 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 3	CN	Jiangsu Hansoh Pharmaceutical Co. Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03903796 (Pubmed \| Aliment Pharmacol Ther) Manual	Phase 3	Hepatitis B, Chronic	1,002	tenofovir amibufenamide	(hzplkreaao) = rdryosixms yuhizifpst (dwxboxielw ) View more	Non-inferior	01 Nov 2021
				tenofovir disoproxil fumarate	(hzplkreaao) = jihnphygiw yuhizifpst (dwxboxielw ) View more
NCT04477096 (Pubmed \| Infect Dis Ther)	Phase 1	-	36	HS-10234 25 mg + Emtricitabine 200 mg	lnidkbanst(tahiizasix) = nlfaxtquqn mlqxggcuwq (yaksdzqihz ) View more	-	30 Oct 2021
				Emtricitabine 200 mg + HS-10234 25 mg	lnidkbanst(tahiizasix) = vtmsjrlnsi mlqxggcuwq (yaksdzqihz ) View more