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TMC435
TMC435 is a protease inhibitor used to treat HIV-1 infection.
TMC435 is a protease inhibitor used to treat HIV-1 infection. Used for Treatment of HIV-1 infection.
At a glance
| Generic name | TMC435 |
|---|---|
| Also known as | TMC 435, G008 |
| Sponsor | Tibotec Pharmaceuticals, Ireland |
| Drug class | protease inhibitor |
| Target | HIV-1 protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
TMC435 works by inhibiting the protease enzyme, which is essential for the replication of the HIV-1 virus. This inhibition prevents the virus from producing new viral particles, thereby reducing the viral load in the body.
Approved indications
- Treatment of HIV-1 infection
Common side effects
- Nausea
- Diarrhea
- Fatigue
Key clinical trials
- Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (PHASE2)
- An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease (PHASE2)
- Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants (PHASE1)
- A Long Term Follow-up Study in Participants Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection (PHASE3)
- A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants (PHASE1)
- A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
- Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection (PHASE4)
- Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TMC435 CI brief — competitive landscape report
- TMC435 updates RSS · CI watch RSS
- Tibotec Pharmaceuticals, Ireland portfolio CI