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Asset Brief

BIT225

BIT·Biotron·Chronic hepatitis B virus (HBV) infection·Preclinical·[ TODO: fill in ]

Plain-language Brief

The trial in plain terms

The disease: Hepatitis B is a liver infection caused by the hepatitis B virus (HBV). Chronic infection, defined as persistence of the virus for more than six months, affects an estimated 254 million people globally (per World Health Organization Global Hepatitis Report 2024). Long-term chronic infection can lead to cirrhosis and hepatocellular carcinoma (liver cancer). Current approved therapies suppress viral replication but rarely achieve a functional cure, meaning most patients require long-term treatment.
What the asset is trying to do: BIT225 is described by Biotron as a viroporin inhibitor (per Biotron ASX announcement, March 2026 Hepatitis B Virus Program Update). Vaporins are small viral proteins that form ion channels in host cell membranes and are thought to assist viral assembly and release. By targeting this ion channel function, BIT225 aims to disrupt HBV replication through a mechanism distinct from approved nucleoside/nucleotide analogue therapies, which work by blocking the viral polymerase enzyme. The specific molecular target of BIT225 in HBV has not been publicly disclosed in the available source material.
What the trial is measuring, and why it matters: BIT225 is currently at the preclinical stage. Biotron has disclosed that a first animal study was completed in June 2025 and assessed safety in that model (per Biotron ASX announcement, March 2026 Hepatitis B Virus Program Update). The company has stated that efficacy studies in animal models are the next planned step (per same announcement). No human clinical trial endpoints have been disclosed because no clinical trial has been registered or initiated.
Efficacy benchmarks in this setting: In the treatment of chronic HBV, approved nucleoside/nucleotide analogue therapies such as tenofovir disoproxil fumarate and entecavir achieve high rates of viral suppression (HBV DNA undetectable) in a substantial proportion of patients on long-term therapy, though rates of hepatitis B surface antigen (HBsAg) loss, considered a functional cure marker, remain low, generally reported at less than 5% per year in treated patients (per European Association for the Study of the Liver EASL Clinical Practice Guidelines on Hepatitis B Virus Infection, Journal of Hepatology 2017 and subsequent updates). Newer combination and novel-mechanism approaches in clinical trials are targeting higher rates of HBsAg loss. BIT225 is at the preclinical stage and has not yet generated clinical efficacy data; early preclinical safety observations are not statistically or methodologically comparable to clinical efficacy figures from approved therapies.
Commercial context: Multiple therapies are approved for chronic HBV, including nucleoside/nucleotide analogues (e.g., tenofovir alafenamide, entecavir) and pegylated interferon alfa (per United States Food and Drug Administration approved drug list). No viroporin inhibitor is currently approved for HBV. BIT225 appears to be Biotron's lead asset in the HBV program based on available ASX disclosures; the company has not publicly disclosed any licensing, partnership, or commercialisation agreements for BIT225 in HBV as of the available announcements. Biotron received a $525,000 research and development tax rebate as disclosed in a June 2026 ASX announcement.

Sources for this brief (6)

Hepatitis B Virus Program Update (ASX Announcement) · Biotron Limited (ASX: BIT) · accessed 15 June 2026
Global Hepatitis Report 2024 · World Health Organization · accessed 15 June 2026
EASL 2017 Clinical Practice Guidelines on the Management of Hepatitis B Virus Infection · European Association for the Study of the Liver, Journal of Hepatology · accessed 15 June 2026
Quarterly Activities/Appendix 4C Cash Flow Report (ASX Announcement, April 2026) · Biotron Limited (ASX: BIT) · accessed 15 June 2026
$525K R&D Rebate Received (ASX Announcement, June 2026) · Biotron Limited (ASX: BIT) · accessed 15 June 2026
Approved Drugs for Hepatitis B · U.S. Food and Drug Administration · accessed 15 June 2026

Trial Design

Design summary

Phase: Preclinical
Design type: [ TODO: fill in ] — no clinical trial registered or disclosed in available data; asset is preclinical.
Primary endpoint: [ TODO: fill in ]
Key secondary endpoints: [ TODO: fill in ]
Enrolment target: [ TODO: fill in ]
Current enrolment status: Not yet recruiting — asset is at preclinical stage; animal efficacy studies are the next planned step (per Biotron ASX announcement, March 2026 Hepatitis B Virus Program Update).
Sites: [ TODO: fill in ]
Expected readout window: [ TODO: fill in ] — no clinical trial timeline has been publicly disclosed; preclinical efficacy study outcomes have not been scheduled in available announcements.

Asset Track Record

Did BIT deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

13 July 2026otherSedarex First Milestone Methitsrc ASX ↗
30 June 2026commercial milestoneBIT225 licensing/partnership deal (via C14 advisory)overdue
30 June 2026data readoutHBV preclinical efficacy data from animal modelsoverdue
3 June 2026other$525K R&D Rebate Receivedhitsrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for BIT225 and peers

BIT225's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for BIT225. Showing past 6 months and next 12 months · 7 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
ConferenceESMO Congress 2026· Madrid

Trial design comparison

How BIT225 reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
BIT225	Biotron	Ion Channel Modulator	Preclinical[ TODO: fill in ]	[ TODO: fill in ] — no clinical trial registered or disclosed in available data; asset is preclinical.	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	0
RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Mechanism trade-offs· 1 classes comparedexpand ›

Mechanism	Speed to patient	Manufacturing	Best approved result	Durability	Moat
Antisense oligonucleotideASO	Off-the-shelf	Synthetic	Approved (SMA/DMD)	Chronic dosing	Moderate

Small Molecule OtherASX peers ›

Curated Commentary

Third-party coverage(none curated yet)

expand ›

External analyst notes, journalism, and industry commentary cited with attribution.

No third-party coverage curated for BIT225 yet. Broker coverage of Biotron is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.

BIT225n = 0

Biotron·Ion Channel Modulator·Preclinical·[ TODO: fill in ]

Design: [ TODO: fill in ] — no clinical trial registered or disclosed in available data; asset is preclinical.
Primary endpoint: [ TODO: fill in ]
Dosing: [ TODO: fill in ]
Eligibility: [ TODO: fill in ]

RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resectionn = —

West China Hospital·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic HBV Infectionn = —

Taichung Veterans General Hospital·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With CHBn = —

Jiangsu Hansoh Pharmaceutical Co., Ltd.·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

TAF to Prevent HBV Reactivation in Cancer Patientsn = —

Chiayi Christian Hospital·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analoguen = —

National Taiwan University Hospital·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of Tenofovir Alafenamide in HBV-Infected Pregnant Womenn = —

First People's Hospital of Hangzhou·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)n = —

Humanity & Health Medical Group Limited·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

The Clinical Cure Project of Chronic Hepatitis B in Chinan = —

Third Affiliated Hospital, Sun Yat-Sen University·Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patientsn = —

Third Affiliated Hospital, Sun Yat-Sen University·Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

ASC22 Combined With Peg-IFNa in Achieving Functional Cure in Patients With Chronic Hepatitis B Virus Infectionn = —

The Second Affiliated Hospital of Chongqing Medical University·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levelsn = —

Asan Medical Center·Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Clinical Efficacy of Pegylated Interferon Alpha-2b Combined With Nucleos(t)Ide Analogues in the Treatment of Chronic Hepatitis B Patientsn = —

Shenzhen Third People's Hospital·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Effects of Empagliflozin on Fibrosis and Cirrhosis in Chronic Hepatitis B Patientsn = —

The University of Hong Kong·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis Bn = —

Taichung Veterans General Hospital·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients With Chronic Hepatitis Bn = —

Nanfang Hospital, Southern Medical University·Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

TAF vs TDF During the Pregancyn = —

The Third Affiliated Hospital of Guangzhou Medical University·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT）n = —

First Affiliated Hospital of Wenzhou Medical University·Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Pegylated Interferon Alfa-2b in Reducing Relapse Rates After Nucleos(t)ide Analogue Withdrawal in HBeAg-negative CHB Patients with Low Level HBsAgn = —

Huashan Hospital·Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis Bn = —

Qing-Lei Zeng·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Active Chronic Hepatitis Bn = —

Qing-Lei Zeng·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelinesn = —

Young-Suk Lim·Small Molecule Other·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infectionn = —

Gilead Sciences·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Entecavir to TAF Switchn = —

Thomas Jefferson University·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)n = —

GlaxoSmithKline·Antisense oligonucleotide·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)n = —

GlaxoSmithKline·Antisense oligonucleotide·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Obeticholic Acid Among Chronic HBV Patients with Hepatic Steatosis : Clinical and Portal Doppler Outcomesn = —

Assiut University·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.n = —

GC Biopharma Corp·Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatmentn = —

Fujian Akeylink Biotechnology Co., Ltd.·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)n = —

Ausper Biopharma Co., Ltd.·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis Bn = —

Zhigang Ren·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in the Treatment of Chronic Hepatitis Bn = —

Grand Theravac Life Sciences (Nanjing) Co., Ltd.·Cancer vaccine·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriersn = —

Sun Yat-sen University·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHBn = —

Shanghai Zhimeng Biopharma, Inc.·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Phase IIIB Extension Clinical Trial of Efficacy and Safety of GST-HG141 (Nairevir) Combined With NAs in Chronic Hepatitis Bn = —

Fujian Akeylink Biotechnology Co., Ltd.·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis Bn = —

Fujian Shengdi Pharmaceutical Co., Ltd.·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosisn = —

Beijing Continent Pharmaceutical Co, Ltd.·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.n = —

Beijing Continent Pharmaceutical Co, Ltd.·Small Molecule Other·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis Bn = —

Xi'an Xintong Pharmaceutical Research Co.,Ltd.·Small Molecule Other·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Clinical Trial to Evaluate the Efficacy and Safety of TQA3810 Tablets in Combination/Non Combination With Nucleoside (Acid) Analogues in Patients With Primary/Treated Chronic Hepatitis Bn = —

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in Treated Patients With Chronic Hepatitis Bn = —

Grand Theravac Life Sciences (Nanjing) Co., Ltd.·Cancer vaccine·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis Bn = —

Fujian Akeylink Biotechnology Co., Ltd.·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Evaluate TQ-A3334 Combined Nucleoside (Acid) Analogs in the First Treatment/Treatment of Chronic HBV Infectionn = —

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patientsn = —

Brii Biosciences Limited·Antisense oligonucleotide·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB)n = —

Ausper Biopharma Co., Ltd.·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIVn = —

National Institute of Allergy and Infectious Diseases (NIAID)·Gpcr Modulator·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in Chronic Hepatitis B Patientsn = —

Grand Theravac Life Sciences (Nanjing) Co., Ltd.·Cancer vaccine·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)n = —

Ausper Biopharma Co., Ltd.·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy of VTP-300 in Chronic Hepatitis B Infectionn = —

Barinthus Biotherapeutics·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB).n = —

Ausper Biopharma Co., Ltd.·Small Molecule Other·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infectionn = —

Vir Biotechnology, Inc.·Antisense oligonucleotide·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

WC
RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection
Phase 4
West China Hospital·Active, not recruiting·Primary completion 1 July 2022·NCT04032860
TV
Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic HBV Infection
Phase 4
Taichung Veterans General Hospital·Active, not recruiting·Primary completion 30 May 2024·NCT05410496
JH
Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With CHB
Phase 4
Jiangsu Hansoh Pharmaceutical Co., Ltd.·Active, not recruiting·Primary completion 30 June 2024·NCT06743438
CC
TAF to Prevent HBV Reactivation in Cancer Patients
Phase 4
Chiayi Christian Hospital·Active, not recruiting·Primary completion 31 Dec 2024·NCT04619082
NT
Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
Phase 4
National Taiwan University Hospital·Active, not recruiting·Primary completion 1 Jan 2025·NCT04496882
FP
Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women
Phase 4
First People's Hospital of Hangzhou·Recruiting·Primary completion 30 Dec 2025·NCT05853718
H&
Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)
Phase 4
Humanity & Health Medical Group Limited·Recruiting·Primary completion 31 Dec 2025·NCT03792919
TS
ASC22 Combined With Peg-IFNa in Achieving Functional Cure in Patients With Chronic Hepatitis B Virus Infection
Phase 4
The Second Affiliated Hospital of Chongqing Medical University·Recruiting·Primary completion 31 Dec 2026·NCT07573943
ST
Clinical Efficacy of Pegylated Interferon Alpha-2b Combined With Nucleos(t)Ide Analogues in the Treatment of Chronic Hepatitis B Patients
Phase 4
Shenzhen Third People's Hospital·Not yet recruiting·Primary completion 31 Dec 2027·NCT07071636
TU
Effects of Empagliflozin on Fibrosis and Cirrhosis in Chronic Hepatitis B Patients
Phase 4
The University of Hong Kong·Active, not recruiting·Primary completion 31 Dec 2027·NCT05147090
TV
Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B
Phase 4
Taichung Veterans General Hospital·Recruiting·Primary completion 31 Dec 2027·NCT03933384
TT
TAF vs TDF During the Pregancy
Phase 4
The Third Affiliated Hospital of Guangzhou Medical University·ENROLLING_BY_INVITATION·Primary completion 1 Dec 2028·NCT07542951
QZ
Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis B
Phase 4
Qing-Lei Zeng·Not yet recruiting·Primary completion 31 Dec 2030·NCT07345624
QZ
Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Active Chronic Hepatitis B
Phase 4
Qing-Lei Zeng·Not yet recruiting·Primary completion 31 Dec 2030·NCT07345611
YL
Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
Phase 4
Young-Suk Lim·Active, not recruiting·Primary completion 31 Dec 2031·NCT03753074
GS
Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
Phase 3
Gilead Sciences·Active, not recruiting·Primary completion 7 Aug 2017·NCT01651403
TJ
Entecavir to TAF Switch
Phase 3
Thomas Jefferson University·Active, not recruiting·Primary completion 15 Aug 2020·NCT03489239
AU
Obeticholic Acid Among Chronic HBV Patients with Hepatic Steatosis : Clinical and Portal Doppler Outcomes
Phase 3
Assiut University·Not yet recruiting·Primary completion 1 Jan 2026·NCT06691412
FA
To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment
Phase 3
Fujian Akeylink Biotechnology Co., Ltd.·Recruiting·Primary completion 1 Dec 2026·NCT07090759
AB
Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)
Phase 3
Ausper Biopharma Co., Ltd.·Active, not recruiting·Primary completion 18 Dec 2026·NCT07246889
ZR
A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B
Phase 3
Zhigang Ren·Recruiting·Primary completion 31 Dec 2026·NCT07307586
SY
Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers
Phase 3
Sun Yat-sen University·Recruiting·Primary completion 15 May 2027·NCT06966232
SZ
A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB
Phase 3
Shanghai Zhimeng Biopharma, Inc.·Not yet recruiting·Primary completion 1 Jan 2028·NCT07095855
FA
Phase IIIB Extension Clinical Trial of Efficacy and Safety of GST-HG141 (Nairevir) Combined With NAs in Chronic Hepatitis B
Phase 3
Fujian Akeylink Biotechnology Co., Ltd.·Not yet recruiting·Primary completion 11 Jan 2028·NCT07588009
FS
Phase III Study of HRS-5635 in Nucleos(t)Ide Analogue-suppressed HBeAg-negative Patients With Chronic Hepatitis B
Phase 3
Fujian Shengdi Pharmaceutical Co., Ltd.·Not yet recruiting·Primary completion 1 June 2028·NCT07606950
BC
Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis
Phase 3
Beijing Continent Pharmaceutical Co, Ltd.·Recruiting·Primary completion 20 June 2028·NCT05905172
BC
A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.
Phase 3
Beijing Continent Pharmaceutical Co, Ltd.·Not yet recruiting·Primary completion 30 Dec 2028·NCT07412236
XX
A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B
PHASE2/PHASE3
Xi'an Xintong Pharmaceutical Research Co.,Ltd.·Active, not recruiting·Primary completion 30 June 2027·NCT07203118
CT
A Clinical Trial to Evaluate the Efficacy and Safety of TQA3810 Tablets in Combination/Non Combination With Nucleoside (Acid) Analogues in Patients With Primary/Treated Chronic Hepatitis B
Phase 2
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Recruiting·Primary completion 1 Sept 2024·NCT06566248
FA
A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B
Phase 2
Fujian Akeylink Biotechnology Co., Ltd.·Recruiting·Primary completion 1 Apr 2025·NCT06263959
CT
Evaluate TQ-A3334 Combined Nucleoside (Acid) Analogs in the First Treatment/Treatment of Chronic HBV Infection
Phase 2
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Active, not recruiting·Primary completion 22 June 2025·NCT06706310
AB
Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB)
Phase 2
Ausper Biopharma Co., Ltd.·Active, not recruiting·Primary completion 21 Oct 2025·NCT06829329
AB
A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)
Phase 2
Ausper Biopharma Co., Ltd.·Not yet recruiting·Primary completion 1 Jan 2026·NCT07137910
BB
Efficacy of VTP-300 in Chronic Hepatitis B Infection
Phase 2
Barinthus Biotherapeutics·Active, not recruiting·Primary completion 1 Feb 2026·NCT05343481
AB
Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB).
Phase 2
Ausper Biopharma Co., Ltd.·Active, not recruiting·Primary completion 2 Feb 2026·NCT06550128

Antisense oligonucleotideASX peers ›

4 activeexpand ›

Class profileexpand ›

Description

Synthetic single-stranded oligonucleotides that bind a target mRNA by Watson-Crick base pairing, either triggering its degradation (RNase H recruitment) or altering its splicing (exon skipping/inclusion). The chemistry is off-the-shelf and small-batch; the principal limiter is not target identification but delivery, since systemic tissue uptake (especially CNS and skeletal muscle) is poor and most approved ASOs require intrathecal or local dosing. ATL1102 (Antisense Therapeutics / Percheron) is an antisense against CD49d (the VLA-4 integrin subunit), an anti-inflammatory target, rather than an exon-skipping dystrophin agent.

Class benchmarks

The class has a real regulatory track record. Approved ASOs include nusinersen (Spinraza, spinal muscular atrophy — a blockbuster), the Sarepta exon-skipping Duchenne series (eteplirsen, golodirsen, casimersen), inotersen, mipomersen and tofersen (ALS). It carries both genuine successes and high-profile efficacy debates: the Duchenne approvals were granted on a surrogate (dystrophin expression) under accelerated approval with confirmatory-trial obligations, and clinical-benefit confirmation has been contentious.

Commercial track record

Spinraza showed multi-billion-dollar potential for a rare-disease ASO before gene-therapy (Zolgensma) and oral competitors arrived. The commercial moat is moderate — sequence and composition-of-matter IP plus a manufacturing and regulatory learning curve — but newer modalities (siRNA, AAV gene therapy) increasingly contest the same rare-disease indications.

Capital intensity

Synthetic oligonucleotide manufacture is well-established and far cheaper than cell or gene therapy. The economic risk is not cost-of-goods but the narrow rare-disease patient pools and the chronic-dosing and delivery burden that shape pricing and adherence.

Regulatory posture

The FDA has repeatedly used accelerated approval on biomarker surrogates for ASOs in rare neuromuscular disease (the Duchenne exon-skippers, tofersen), lowering the evidentiary bar to first approval but attaching confirmatory-trial risk. For an anti-inflammatory ASO such as ATL1102 the path is less templated: the target is not a splicing correction, so the pivotal endpoint would likely need to be a functional clinical measure rather than a protein biomarker.

Class sources (4)

Spinraza (nusinersen) prescribing information · FDA · accessed 29 May 2026
Amondys 45 / Exondys 51 (casimersen, eteplirsen) prescribing information · FDA · accessed 29 May 2026
Percheron Therapeutics (formerly Antisense Therapeutics) — ATL1102 program · Percheron Therapeutics · accessed 29 May 2026
Crooke ST et al — Antisense technology: an overview and prospectus (Nat Rev Drug Discov 2021) · Nature Reviews Drug Discovery · accessed 29 May 2026

G
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)
Phase 3
GlaxoSmithKline·Active, not recruiting·Primary completion 3 Nov 2025·NCT05630820
G
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)
Phase 3
GlaxoSmithKline·Active, not recruiting·Primary completion 11 Nov 2025·NCT05630807
BB
Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients
Phase 2
Brii Biosciences Limited·