First FDA-Approved Treatment for Chronic Hepatitis D

Hepcludex (bulevirtide; in the United States, bulevirtide-gmod) is a once-daily subcutaneous entry inhibitor. It is a 47-amino-acid lipopeptide that blocks NTCP, the receptor hepatitis D uses to get into liver cells. Hepatitis D only infects people who already have hepatitis B. It is not interferon, not a nucleoside analogue, and not a cure. Underlying HBV still has to be managed.

The United States labelled dose is 8.5 mg once daily. Canada, the European Union, the United Kingdom, Australia, and Switzerland label 2 mg once daily (children in the EU, UK, and Switzerland use a weight-based volume from the 2 mg vial). Those are different vials, different reconstitution volumes, and different labels. A US 8.5 mg carton is not a Canadian 2 mg prescription.

The FDA granted accelerated approval on 22 May 2026. Health Canada issued a Notice of Compliance on 8 August 2025 — a full NOC, not a Notice of Compliance with Conditions. The European Commission first authorised Hepcludex under a conditional marketing authorisation on 31 July 2020 and converted it to a standard authorisation on 18 July 2023.

This is not a cure. US continued approval depends on a confirmatory outcomes study. Optimal treatment duration is unknown on every label. Stopping can make hepatitis D and B flare, especially if there is cirrhosis.

Where this is taking place

Commercial labelled supply is the door, not a recruiting Phase 3.

United States — FDA-labelled 8.5 mg SC daily (accelerated). Viral-hepatitis / hepatology clinic.

Canada — Health Canada-labelled 2 mg SC daily (full NOC, marketed). Viral-hepatitis / hepatology or infectious-disease clinic experienced in HDV. Authorized ≠ funded.

European Union — EC-labelled 2 mg (adults; children ≥3 years and ≥10 kg on a weight-based volume from the same 2 mg vial). Physician experienced in HDV.

United Kingdom — MHRA-labelled 2 mg, same paediatric line as the EU. NICE and SMC restrict who the NHS pays for more tightly than the licence.

Australia — TGA-labelled 2 mg, adults with compensated liver disease. PBS listing not confirmed.

Switzerland — Swissmedic-labelled 2 mg, including the 2025 paediatric extension.

MYR301 (NCT03852719) — Phase 3, open-label, randomised, COMPLETED (CT.gov completion 8 Aug 2024). Sponsor: Gilead Sciences. 150 adults, 18–65, chronic HDV, compensated liver disease. Arms: delayed treatment (observe 48 weeks, then the protocol 10 mg / US-delivered 8.5 mg for 96 weeks); immediate 2 mg for 144 weeks; immediate 10 mg (US-delivered 8.5 mg) for 144 weeks. Then 96 weeks off treatment. Sites listed in the United States, Germany, Italy, Russia, and Sweden. Enrolled (results narrative): Germany, Italy, Russia, Sweden. No Canadian sites. This trial is finished. It is not an enrolment path.

MYR204 (NCT03852433) — Phase 2b supportive for the US 8.5 mg line. Not an enrolment path.

NCT05718700 — Gilead observational registry, ACTIVE_NOT_RECRUITING. People already on labelled bulevirtide. Not a way to start the drug.

GS-EU-589-6575 — FDA confirmatory observational study vs historical control (multidisciplinary review; EMA RWD catalogue). Anticipated completion 2033. No public NCT found. Not a clinic you call to enrol from this article.

EAP NCT06780579 — APPROVED_FOR_MARKETING, ages 18+, 0 locations on CT.gov. Intervention line 10 mg — not the US labelled 8.5 mg vial and not the Canadian 2 mg DIN. Not a labelled-dose access path.

The practical door is the hepatology or viral-hepatitis clinic that already manages the hepatitis B — not Special Access Programme paperwork for a labelled DIN, and not a suitcase of the other country's vial.

Approval matrix

Access by country

• United States: Viral-hepatitis / hepatology clinic. FDA-labelled 22 May 2026 for adults with chronic HDV without cirrhosis or with compensated cirrhosis. 8.5 mg once daily by subcutaneous injection after reconstituting the 8.5 mg vial with 1 mL sterile water; inject the entire contents. Train on reconstitution; consider the first dose under a clinician. Continue as long as there is a response; optimal duration unknown. Manage HBV as clinically appropriate. Store vials at room temperature 20–25 °C; use immediately after mixing. Sterile water, syringes, and needles come separately from the pharmacy. Gilead US (USPI): HEPCLUDEX.com or 1-800-445-3235. Support Path is named in company materials — no copay dollars here. Prior authorization still applies. Children are not labelled. This is accelerated approval. A Canadian or EU 2 mg vial is not a substitute for the US 8.5 mg product.

• Canada (zoom): Authorized (full NOC) 8 Aug 2025. DIN 02560178. Marketed (DPD status date 7 Oct 2025). Ask the hepatologist or infectious-disease specialist who already manages the hepatitis B for a 2 mg once-daily subcutaneous prescription. Authorized ≠ funded. CDA-AMC SR0881-000 (final rec 22 Dec 2025) recommended public-plan reimbursement with conditions (adult, compensated, anti-HDV +, HDV RNA within 6 months, ALT 1–<10 × ULN, albumin > 28 g/L, specialist prescriber, price reduction, 48-week virologic renewal). That is not a provincial listing. pCPA 23353 is in negotiation. INESSS January 2026 recommended refus d'inscription; minister decision not confirmed. Other provinces, territories, and NIHB: unknown. SAP is the wrong door for a labelled, marketed DIN. Gilead Canada medical information on the Product Monograph: 1-866-207-4267 / www.gilead.ca — medical information, not a copay program. Store in the refrigerator (2–8 °C). Pediatrics not authorised. Do not mail-order a US 8.5 mg bottle. Do not escalate a non-responder to 8.5 mg or 10 mg on a Canadian script — those doses are not Health Canada–authorised (CDEC noted 5 mg and 10 mg are not approved in Canada).

• United Kingdom: MHRA authorised 25 Jun 2024 (PLGB 11972/0053), 2 mg, including children ≥3 / ≥10 kg on the SmPC. NICE TA896 (7 Jun 2023) recommends use in adults with compensated disease only if significant fibrosis (F2+ / Ishak 3+) and PEG-IFN has failed or cannot be used, and the commercial arrangement is in place. Scotland: SMC2520 accepted for restricted use (13 Mar 2023) with the same restriction and a PAS. Ask the HDV clinic; do not assume every licensed patient is NHS-funded. Start under a physician experienced in HDV. Store refrigerated.

• European Union: EC licence, now standard. 2 mg daily for HDV-RNA–positive adults and children ≥3 / ≥10 kg with compensated liver disease. Physician experienced in HDV. Member-state reimbursement is not the EC licence — reimbursement outside NICE/SMC is unknown. Named-patient import of a US 8.5 mg vial is not a DIY order.

• Australia: TGA-labelled 30 Jul 2024, 2 mg, adults with compensated liver disease. ARTG 407179. PBAC has recommended a listing; whether it is on the PBS is unknown. Specialist + local special-access only if those programs apply and the product is not yet funded.

• Switzerland: In-country commercial after Swissmedic 5 Feb 2024 (adults) and 16 Jul 2025 (children ≥3 / ≥10 kg). 2 mg. Reimbursement unknown.

• Japan / China / other regulators: Authorisation not confirmed. Do not import on your own.

If your regulator has not authorised it: do not import on your own. Travelling to a labelled market is a plan with both specialists, not a suitcase protocol. Do not mix an 8.5 mg US vial with a 2 mg EU/Canada vial.

Who is eligible (from the labels — they are not the same)

This is an HDV RNA + hepatitis B conversation. Hepcludex does not replace HBV treatment.

United States (USPI) — 8.5 mg:

• Adult.
• Chronic HDV infection.
• Without cirrhosis or with compensated cirrhosis.
• 8.5 mg SC once daily. Continue while associated with a response. Optimal duration unknown.
• Manage underlying HBV as clinically appropriate.
• Not established under 18. Geriatric: trials did not include ≥65.
• No dose adjustment described for mild/moderate/severe renal impairment (CrCl ≥15 mL/min); ESRD (CrCl <15) not studied. No dose adjustment for mild hepatic impairment (Child-Pugh A); moderate/severe (B/C) not studied.
• Contraindications: none.
• Accelerated: clinical-outcome benefit not established.

Canada (Product Monograph / SBD / RDS) — 2 mg:

• Adult.
• Chronic HDV infection with compensated liver disease.
• 2 mg SC once daily. Continue while associated with clinical benefit. Optimal duration unknown.
• Manage underlying HBV simultaneously; monitor HBV DNA.
• Pediatrics not authorised. Geriatrics: no patients ≥65 in the trials.
• Mild renal impairment (CrCl ≥60 and <90): no adjustment on limited data; CrCl <60 no dosing data. Child-Pugh A: no adjustment; B/C and decompensated no data.
• Contraindication: hypersensitivity to bulevirtide or any ingredient.
• NOC is a full authorisation, not conditional. Funding is separate.
• CDA-AMC reimbursement recommendation (not the label) would further restrict public coverage (RNA within 6 months, ALT 1–<10 × ULN, albumin >28 g/L, specialist, no concurrent PEG-IFN) — that is HTA, not Health Canada's indication.

European Union and United Kingdom (SmPC 4.1) — 2 mg (weight-based in children):

• Plasma or serum HDV-RNA positive.
• Adults, and children 3 years of age and older weighing at least 10 kg.
• Compensated liver disease.
• Adult dose 2 mg once daily (every 24 hours ± 4 hours).
• Children: 10–<25 kg 1 mg (0.5 mL); 25–<35 kg 1.5 mg (0.75 mL); ≥35 kg 2 mg (1 mL) — all from the 2 mg vial. Paediatric dosing is from modelling, not a paediatric efficacy trial.
• Start only by a physician experienced in HDV.
• Contraindication: hypersensitivity.
• Decompensated cirrhosis: not recommended.
• Preferable to avoid in pregnancy and in women of childbearing potential not using contraception (EU/UK).
• Paediatric dosing (≥3 years and ≥10 kg) is on the EU, UK, and Swiss labels only — not the US or Canadian label.

Australia (TGA AusPMD) — 2 mg:

• Adults with compensated liver disease. 2 mg. Not the US dose. Paediatric extension not on the AusPMD indication retrieved.

Switzerland (Swissmedic) — 2 mg:

• HDV-RNA positive, compensated liver disease; from 16 Jul 2025, children ≥3 / ≥10 kg as well. 2 mg / weight-based as EU.

Not labelled:

• Decompensated cirrhosis / Child-Pugh B or C (every label: not studied / not recommended).
• Children in the United States or Canada.
• Using a US 8.5 mg vial in Canada, the EU, the UK, Australia, or Switzerland — or a 2 mg vial as the US labelled dose.
• Escalating a Canadian/EU 2 mg non-responder to 10 mg because MYR301 had a 10 mg arm. Health Canada did not authorise 10 mg; the US authorised the recovered 8.5 mg product, not a Canadian titration.

What the pivotal study showed (label vs journal)

Use the label of the country that will prescribe. The US 8.5 mg results and the EU/Canada 2 mg results are separate labelled tables.

MYR301 randomised 150 adults 1:1:1 to delayed treatment, immediate 2 mg, or immediate protocol-10 mg (US-delivered 8.5 mg). Open-label. Mean age ~41–44. About half had compensated cirrhosis. Almost all HDV genotype 1. The primary endpoint was combined response at Week 48: HDV RNA undetectable or ≥2 log10 drop, and ALT normalisation.

FDA / USPI (immediate 8.5 mg n=50 vs delayed n=51), Week 48:

• Combined response: 48% vs 2% (rate difference 46%, 96% CI 31–61; p<0.0001).
• Virologic response: 76% vs 4%.
• ALT normalisation: 56% vs 12%.
• Undetectable HDV RNA: 20% vs 0%.
• Week 96 / 144 (immediate 8.5 mg): combined 56% / 54%; undetectable 36% / 50%.
• Posttreatment Week 24 / 96 combined response in the immediate group: 32% / 24%. Stopping is not a small decision.

Health Canada PM / EMA–MHRA SmPC (immediate 2 mg n=49 vs delayed n=51), Week 48:

• Combined response: 45% (HC: 44.9%, 95% CI 30.7–59.8) vs 2% (p<0.0001). HC difference 42.9% (96% CI 27.0–58.5).
• Virologic response: 71% (EMA) / 73.5% (HC) vs 4% / 3.9%.
• ALT normalisation: 51% vs 12%.
• Undetectable HDV RNA: 12% (HC 12.2%) vs 0%.
• Key secondary 10 mg vs 2 mg undetectable at Week 48: difference 7.8%, not statistically significant (p=0.4139). That is why Canada and Europe stayed at 2 mg.

Journal (Wedemeyer et al., N Engl J Med 2023;389:22-32): same trial, Week 48. Not a preprint. Combined response 45% (2 mg) / 48% (10 mg) / 2% (control). The journal 10 mg arm is not a Canadian prescription dose.

This is HDV RNA drop plus ALT normalisation on an open-label trial. US accelerated approval says clinical benefit still has to be verified. It is not a proven reduction in transplant, cancer, or death at 48 weeks.

How it is taken (labelled — the vial is not the same)

United States: 8.5 mg once daily SC. Reconstitute the 8.5 mg vial with 1 mL sterile water. Inject the entire contents. Sites: upper thigh, lower abdomen, or back of upper arm (caregiver only). Rotate; skip a 1-inch circle around the navel. Use immediately. Vials at room temperature 20–25 °C. Carton of 30 = 30-day supply. Water, syringes, and needles are not in the carton.

Canada / EU / UK / Australia / Switzerland: 2 mg once daily SC. Reconstitute the 2 mg vial with 1 mL sterile water (resulting concentration 2 mg/mL in Canada). Adults inject 1 mL. EU/UK/Swiss children inject 0.5 / 0.75 / 1.0 mL by weight. Sites: upper thigh or abdomen (Canada also lists caregiver upper arm). Refrigerate 2–8 °C in the carton, protected from light. Use immediately (in-use stability up to 2 hours at ≤25 °C is described; labels still say use immediately). Do not shake.

Missed dose — they are not worded the same:

• US / Canada: take as soon as possible the same day; if it is almost time for the next dose, skip; do not double.
• EU / UK: if <4 hours late, inject now and keep the original schedule the next day; if >4 hours late, skip and take the next day on time; do not double.

Optimal duration unknown. EU/UK: consider stopping after 6 months of sustained HBsAg seroconversion or loss of virologic and biochemical response.

Do not mix other drugs in the syringe.

Safety (from the labels)

United States — BOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B

Severe acute exacerbations of hepatitis D and hepatitis B may occur after Hepcludex is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Monitor hepatic function closely with both clinical and laboratory follow-up, including HBV DNA and HDV RNA, for at least six months in patients who discontinue. Resumption of antiviral therapy may be warranted.

Hypersensitivity including anaphylaxis (US Warnings): stop immediately and treat. US contraindications: none.

Most common AEs ≥10% at Week 48, 8.5 mg (n=50) vs delayed (n=51): injection site reactions 30% vs 0; headache 20% vs 0; abdominal pain 18% vs 2%; fatigue 14% vs 2%; pruritus 14% vs 0. No one discontinued for an AE through Week 48. Eosinophil increase 33% (all Grade 1). All 8.5 mg recipients had elevated bile salts; 14% had Grade 1–2 pruritus.

Canada — Serious Warnings and Precautions box (PM): severe acute exacerbations of HDV and HBV may occur after discontinuation. Monitor at least several months. Resumption may be warranted.

Contraindication (Canada): hypersensitivity.

MYR301 2 mg Week 48 (PM Table 2, n=49 vs 51): injection site reactions 18.4% vs 0; headache 18.4% vs 0; pruritus 12.2% vs 0; fatigue 10.2% vs 2.0%; nausea 6.1% vs 3.9%; dizziness 4.1% vs 0. Post-market: hypersensitivity including anaphylaxis.

EU / UK SmPC: very common — raised bile salts, headache, pruritus, injection site reactions. Common — eosinophilia, dizziness, nausea, arthralgia, fatigue, influenza-like illness. Uncommon — hypersensitivity including anaphylactic reaction. Most frequent serious reaction: hepatitis flare after stopping.

Every country: do not stop without the clinic. Refill before the carton is empty. New or unusual symptoms after a stop → call.

Pregnancy / breastfeeding: human data insufficient. US: unknown whether present in milk. EU/UK: preferable to avoid in pregnancy and in women of childbearing potential not using contraception; decide breast-feeding vs treatment. Canada: use in pregnancy only if potential benefit justifies potential risk.

Do not co-administer (EU/UK/Canada examples of NTCP inhibitors, not a complete list): sulfasalazine, irbesartan, ezetimibe, ritonavir, ciclosporin A (Canada also lists simvastatin among "not recommended"). Statins and some thyroid hormones may need extra monitoring as NTCP substrates. That is a clinic conversation, not a self-edit.

Research team (Who)

Names below appear on NCT, label, SBD, SmPC, or the NEJM paper.

• Gilead Sciences, Inc. — US BLA holder, U.S. License 2258, Foster City, CA; MYR301 / MYR204 sponsor (CT.gov).
• Gilead Sciences Canada, Inc., Mississauga, ON — Canadian MAH (SBD, DPD, PM).
• Gilead Sciences Ireland UC, Carrigtohill, Cork — EU MAH (EPAR / SmPC).
• Gilead Sciences Ltd, London — UK MAH (eMC SmPC).
• Gilead Sciences Pty Ltd — Australian sponsor (TGA AusPMD).
• Gilead Sciences Switzerland Sàrl — Swiss MAH (SwissPAR).
• MYR GmbH / MYR Pharmaceuticals — originator; Gilead acquired the asset (historical; current MAHs are Gilead entities above).
• Heiner Wedemeyer — NEJM MYR301 first author (N Engl J Med 2023;389:22-32).
• Ira Jacobson, MD, NYU Grossman School of Medicine — quoted in Gilead's 22 May 2026 FDA announcement. Company-quoted clinician, not a CT.gov principal investigator.
• No Canadian principal investigator is named because MYR301 lists no Canadian sites.

How to talk to a doctor

Bring the NCT number and the label of the country you are in. The dose is not interchangeable.

1. "Have I been tested for HDV RNA, not just HBsAg? If I have hepatitis B, should HDV be checked?"
2. "I have chronic HDV and compensated liver disease. In Canada / EU / UK / Australia / Switzerland, is Hepcludex 2 mg SC daily the labelled next step? In the United States, is it Hepcludex 8.5 mg SC daily?"
3. "Please do not copy the US 8.5 mg vial onto a Canadian or EU script, or the 2 mg vial onto a US script."
4. "How do we manage my hepatitis B at the same time (tenofovir, entecavir, or whatever is already working)?"
5. "Show me reconstitution and the first injection. What supplies come from the pharmacy vs the carton?"
6. "If I stop, what is the flare-watch plan — six months of HBV DNA and HDV RNA (US) / several months (Canada)?"
7. "Allergic symptoms (wheeze, swelling, severe rash) — stop and emergency care. Canada and Europe list hypersensitivity as a contraindication; the US lists none but still warns for anaphylaxis."
8. "Statins, ciclosporin, ezetimibe, sulfasalazine, irbesartan, ritonavir — do any of my medicines block NTCP?"
9. Canada: "This is a full NOC, marketed, DIN 02560178, 2 mg. SAP is the wrong door. What is actually funded in this province? I do not have a listing answer."
10. UK: "MHRA yes at 2 mg; NICE TA896 and SMC2520 are restricted (F2+ and interferon-experienced or interferon-ineligible). Am I in the funded group?"
11. US: "This is accelerated 8.5 mg. Clinical benefit is still being confirmed. Is prior authorization started?"
12. Children: "Only the EU, UK, and Swiss labels include ≥3 years and ≥10 kg, from the 2 mg vial. Not the US or Canadian label."

Canada zoom: authorized, not funded-by-default

Health Canada has already authorised Hepcludex with a full NOC, and it is on the market at 2 mg. That is not a compassionate-access story and not an FDA-only story. The remaining Canadian questions are who pays (unknown) and not using a US 8.5 mg vial. Do not call the clinic asking for SAP. Do not assume a provincial formulary has listed it because a DIN exists. Do not ask the specialist to "just use the American dose."

Bottom line

Hepcludex is the first labelled drug for chronic hepatitis D. The United States labels 8.5 mg subcutaneously once daily (FDA accelerated, 22 May 2026) for adults without cirrhosis or with compensated cirrhosis. Canada (full NOC, 8 Aug 2025), the EU, UK, Australia, and Switzerland label 2 mg once daily — Canada and Australia in adults with compensated liver disease; the EU, UK, and Switzerland also in children ≥3 years and ≥10 kg. Those doses are not interchangeable. MYR301 is completed and had no Canadian sites. Authorized is not funded. SAP is the wrong door. The door is a viral-hepatitis clinic writing the labelled dose of that country.

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Primary sources

1. DailyMed HEPCLUDEX (bulevirtide-gmod), setid 12391cc2-38c2-4cf5-86d3-2be9370127fc, revised May 2026 — https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=12391cc2-38c2-4cf5-86d3-2be9370127fc
2. FDA accelerated-approval bulletin, 22 May 2026 — https://content.govdelivery.com/accounts/USFDA/bulletins/4188fc8
3. FDA multidisciplinary review, BLA 761468, 21 May 2026 — https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/761468Orig1s000MultidisciplineR.pdf
4. Gilead FDA announcement, 22 May 2026 (company; confirmatory "already initiated") — https://www.gilead.com/news/news-details/2026/fda-grants-accelerated-approval-to-gileads-hepcludex-bulevirtide-gmod-the-first-and-only-approved-treatment-for-chronic-hepatitis-delta-virus-hdv
5. Health Canada Regulatory Decision Summary, RDS1761159046187, NOC 8 Aug 2025, DIN 02560178, 2 mg — https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1761159046187
6. Health Canada Summary Basis of Decision, SBD1759323925454, issued 29 Sep 2025 — https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1759323925454
7. Health Canada DHPP product page (Marketed, status date 2025-10-07, DIN 02560178) — https://dhpp.hpfb-dgpsa.ca/dhpp/resource/106325
8. Canadian Product Monograph, Date of Authorization 2025-08-08, HRES 00081315 — https://pdf.hres.ca/dpd_pm/00081315.PDF
9. Canadian Product Monograph (Gilead Canada host) — https://www.gilead.com/en-ca/-/media/gilead-canada/pdfs/product-monographs/hepcludex-english-pm.pdf
10. EMA EPAR Hepcludex (conditional 31 Jul 2020 → standard 18 Jul 2023; paediatric ≥3 / ≥10 kg; 2 mg) — https://www.ema.europa.eu/en/medicines/human/EPAR/hepcludex
11. EU SmPC / EPAR product information (EN PDF) — https://www.ema.europa.eu/en/documents/product-information/hepcludex-epar-product-information_en.pdf
12. MHRA / eMC SmPC, PLGB 11972/0053, first authorisation 25 Jun 2024, revision 14 Apr 2026 — https://www.medicines.org.uk/emc/product/13482/smpc
13. NICE TA896, published 7 Jun 2023 — https://www.nice.org.uk/guidance/ta896
14. NICE TA896 recommendations — https://www.nice.org.uk/guidance/ta896/chapter/1-Recommendations
15. SMC2520, published 13 Mar 2023 — https://scottishmedicines.org.uk/medicines-advice/bulevirtide-hepcludex-full-smc2520/
16. TGA AusPMD Hepcludex (bulevirtide acetate), approved 30 Jul 2024, ARTG 407179 — https://www.tga.gov.au/resources/auspmd/hepcludex-bulevirtide-acetate
17. PBAC July 2025 outcomes (recommended) — https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2025-07/pbac-web-outcomes-07-2025-v4.pdf
18. PBAC March 2026 PSD (resubmission) — https://www.pbs.gov.au/industry/pbac/psd/2026/03/bulevirtide-psd-march-2026-y2026034
19. Swissmedic summary report, paediatric extension 16 Jul 2025 (first authorisation 5 Feb 2024) — https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/swisspar-public/hepcludex-wirkstoff-bulevirtid-01.pdf.download.pdf/Kurzbericht%20Arzneimittelzulassung%20Hepcludex%20(02)_ENG.pdf
20. SwissPAR Hepcludex, MA 68338, 16 Jul 2025 — https://www.swissmedic.ch/dam/swissmedic/it/dokumente/zulassung/swisspar/68338-hepcludex-02-swisspar-20251128.pdf.download.pdf/Assessment_Report_SwissPAR_Hepcludex.pdf
21. CDA-AMC SR0881 reimbursement recommendation, January 2026 (June 2026 albumin correction) — https://www.cda-amc.ca/sites/default/files/DRR/2026/SR0881-Hepcludex_Recommendation.pdf
22. ClinicalTrials.gov MYR301 NCT03852719 — https://clinicaltrials.gov/study/NCT03852719
23. ClinicalTrials.gov MYR204 NCT03852433 — https://clinicaltrials.gov/study/NCT03852433
24. ClinicalTrials.gov registry NCT05718700 — https://clinicaltrials.gov/study/NCT05718700
25. EMA HMA catalogue, GS-EU-589-6575 confirmatory observational study — https://catalogues.ema.europa.eu/node/4364/administrative-details
26. Wedemeyer H, et al. A Phase 3, Randomized Trial of Bulevirtide in Chronic Hepatitis D. N Engl J Med. 2023;389:22-32. DOI 10.1056/NEJMoa2213429. PMID 37345876 (journal; not the label; not a preprint)