Wednesday, July 8, 2026

Drug profile · INN

entecavir

entecavir (ENTAC) is a dna polymerase/reverse transcriptase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antiinfectives for systemic use (J05) J05AF10
US status approved
Patents linked 3
Pipeline programs 23
News articles 0
Drug details — entecavir
US status
approved
Class
Antiinfectives for systemic use (J05)
Route
ORAL
Patents
3
Programs
23
Data quality
0.89

Quick answer

entecavir (ENTAC) is a dna polymerase/reverse transcriptase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN entecavir
Brand ENTAC
Mechanism DNA polymerase/reverse transcriptase inhibitor
Target DNA polymerase/reverse transcriptase
Therapeutic class Antiinfectives for systemic use (J05)
Route ORAL
Formulation SOLUTION
ATC code J05AF10

Mechanism of action

DNA polymerase/reverse transcriptase inhibitor

Primary target: DNA polymerase/reverse transcriptase

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. CVAY736F12301 Phase 3 · Novartis India · Systemic Lupus Erythematosus
  2. CVAY736F12302 Phase 3 · Novartis India · Systemic Lupus Erythematosus
  3. CVAY736K12301 Phase 3 · Novartis India · Lupus nephritis
  4. CVAY736K12301E1 Phase 3 · Novartis India · Lupus nephritis
  5. CVAY736O12301 Phase 3 · Novartis India · warm autoimmune haemolytic anaemia (wAIHA)
  6. CVAY736Q12301 Phase 3 · Novartis India · Primary immune thrombocytopenia (ITP)
  7. Entecavir Phase 3 · HOFFMANN-LA ROCHE · Pediatric Immuno-Tolerant Chronic Hepatitis B
  8. Entecavir Phase 3 · Bristol Myers Squibb · Hepatitis B, Chronic

Related & competitor drugs

  1. atazanavir sulfate Antiinfectives for systemic use (J05)
  2. colistimethate sodium Antiinfectives for systemic use (J01)
  3. covid-19 mrna vaccine Antiinfectives for systemic use (J07)
  4. daptomycin Antiinfectives for systemic use (J01)
  5. darunavir Antiinfectives for systemic use (J05)
  6. dengue tetravalent vaccine (live, attenuated) Antiinfectives for systemic use (J07)
  1. US 9149538

    Oligomer conjugates of heteropentacyclic nucleosides

    Expires Mon Oct 01 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 8778898

    Oligomer conjugates of heteropentacyclic nucleosides

    Expires Mon Jul 10 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 8466276

    Oligomer conjugates of heteropentacyclic nucleosides

    Expires Mon Jun 13 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is entecavir?

entecavir (ENTAC) is a dna polymerase/reverse transcriptase inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for entecavir?

ENTAC is a marketed brand name for entecavir. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of entecavir?

entecavir has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.