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 Disorders

Active Indication

Hepatitis B, Chronic

Inactive Indication

HIV Infections

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

[+35]

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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17

Literatures (Medical) associated with Tenofovir amibufenamide

01 Nov 2024·International Journal of Pharmaceutics

Preparation of tenofovir amibufenamide fumarate spherical particles to improve tableting performance and sticking propensity by designing a spherical crystallization process

Article

Author: Zhao, Chenyang ; Wang, Xiaolei ; Liu, Yanbo ; Chen, Mingyang ; Gong, Junbo ; Chen, Weiqi ; Lian, Xiaogang ; Wu, Songgu ; He, Lei ; Wang, Shuo

Tenofovir amibufenamide fumarate (TMF) is the first oral drug developed in Asia for the treatment of adult patients with chronic viral hepatitis B, however, further applications are limited by poor tableting performance and high sticking propensity. In this work, the spherulitic growth process of TMF has been designed and explored with the help of molecular dynamics simulation and process analysis technologies (ATR-FTIR, FBRM and EasyViewer). The spherical particles with high bulk density, good flowability and uniform particle size distribution are prepared by a simple quenching process. More importantly, experimental results show that spherical particles have higher average tensile strength (100.8% increase), higher plastic deformability and lower amount of punch sticking (87.4% decrease in 30 tablets) compared to the commercial powder products. These contributions not only shed light on the design principle of drug spherulitic growth processes, but also provide guidance for the manufacture of high-quality tablet products.

20 Oct 2024·Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology

[Efficacy evaluation of extending or switching to tenofovir amibufenamide in patients with chronic hepatitis B: a phase Ⅲ randomized controlled study].

Article

Author: Zhang, X Q ; Jin, Q L ; Liu, Z H ; Gao, Z L ; Chen, E Q ; Zhang, Y X ; Yin, H F ; Wu, G C ; Niu, J Q ; Mao, Q ; Shang, J ; Jin, C N ; Yao, L F ; Huang, Y ; Li, C ; Zhong, L H ; Gong, H Y ; Lin, S D ; Gong, G Z ; Wen, X F ; Gao, Q J ; Wang, F M ; Yang, D K ; Hu, P ; Hou, J L

Objective: In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the efficacy of sequential TMF treatment from 96 to 144 weeks. Methods: Enrolled subjects who were previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extended or switched TMF treatment for 48 weeks. Efficacy was evaluated based on virological, serological, biological parameters, and fibrosis staging. Statistical analysis was performed using the McNemar test, t-test, or Log-Rank test according to the data. Results: 593 subjects from the initial TMF group and 287 subjects from the TDF group were included at week 144, with the proportions of HBV DNA<20 IU/ml at week 144 being 86.2% and 83.3%, respectively, and 78.1% and 73.8% in patients with baseline HBV DNA levels ≥8 log10 IU/ml. Resistance to tenofovir was not detected in both groups. For HBeAg loss and seroconversion rates, both groups showed a further increase from week 96 to 144 and the 3-year cumulative rates of HBeAg loss were about 35% in each group. However, HBsAg levels were less affected during 96 to 144 weeks. For patients switched from TDF to TMF, a substantial further increase in the alanine aminotransferase (ALT) normalization rate was observed (11.4%), along with improved FIB-4 scores. Conclusion: After 144 weeks of TMF treatment, CHB patients achieved high rates of virological, serological, and biochemical responses, as well as improved liver fibrosis outcomes. Also, switching to TMF resulted in significant benefits in ALT normalization rates (NCT03903796).

20 Oct 2024·Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology

[Safety profile of tenofovir amibufenamide therapy extension or switching in patients with chronic hepatitis B: a phase Ⅲ multicenter, randomized controlled trial].

Article

Author: Jin, Q L ; Zhang, X Q ; Liu, Z H ; Gao, Z L ; Xia, P ; Chen, E Q ; Zhang, Y X ; Yin, H F ; Wu, G C ; Niu, J Q ; Mao, Q ; Shang, J ; Yao, L F ; Huang, Y ; Li, C ; Zhong, L H ; Gong, H Y ; Lin, S D ; Wen, X F ; Gong, G Z ; Gao, Q J ; Wang, F M ; Yang, D K ; Hu, P ; Hou, J L

Objective: In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the safety profile of sequential TMF treatment from 96 to 144 weeks. Methods: Enrolled subjects that previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extending or switching TMF treatment for 48 weeks. Safety profiles of kidney, bone, metabolism, body weight, and others were evaluated. Results: 666 subjects from the initial TMF group and 336 subjects from TDF group with at least one dose of assigned treatment were included at week 144. The overall safety profile was favorable in each group and generally similar between extended or switched TMF treatments from week 96 to 144. In subjects switching from TDF to TMF, the non-indexed estimated glomerular filtration rate (by non-indexed CKD-EPI formula) and creatinine clearance (by Cockcroft-Gault formula) were both increased, which were (2.31±8.33) ml/min and (4.24±13.94) ml/min, respectively. These changes were also higher than those in subjects with extending TMF treatment [(0.91±8.06) ml/min and (1.30±13.94) ml/min]. Meanwhile, switching to TMF also led to an increase of the bone mineral density (BMD) by 0.75% in hip and 1.41% in spine. On the other side, a slight change in TC/HDL ratio by 0.16 (IQR: 0.00, 0.43) and an increase in body mass index (BMI) by (0.54±0.98) kg/m² were oberved with patients switched to TMF, which were significantly higher than that in TMF group. Conclusion: CHB patients receiving 144 weeks of TMF treatment showed favorable safety profile. After switching to TMF, the bone and renal safety was significantly improved in TDF group, though experienceing change in metabolic parameters and weight gain (NCT03903796).

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	Preclinical	CN	Jiangsu Hansoh Pharmaceutical Co. Ltd.	03 Aug 2020

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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	(swtdmjvcrd) = zbjmqaqkyu gvizujpmle (lauigxhtqr ) View more	Non-inferior	01 Nov 2021
				tenofovir disoproxil fumarate	(swtdmjvcrd) = itfvbnrpib gvizujpmle (lauigxhtqr ) View more
NCT04477096 (Pubmed \| Infect Dis Ther)	Phase 1	-	36	HS-10234 25 mg + Emtricitabine 200 mg	mnvtuvqmex(gheicsxzeg) = fnavgxkign wlptklfzdk (udnoikklld ) View more	-	30 Oct 2021
				Emtricitabine 200 mg + HS-10234 25 mg	mnvtuvqmex(gheicsxzeg) = kmghdrenij wlptklfzdk (udnoikklld ) View more