Rifapentine
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | PRIFTIN | — | 2000-10-20 – 2014-11-25 | fda.gov ↗ |
| Approved | US (FDA) | PRIFTIN | — | 1998-06-22 | fda.gov ↗ |
Trials 63 · started per year
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2019-11-08 | Gilead Sciences | Results Gilead Announces New Data from Viral Hepatitis Research Programs at The Liver Meeting® 2019 gilead.com ↗
Through three or five years of follow-up, dependent on cohort, HCC was observed in 21 patients (1.0 percent in the TAF group; 1.9 percent in the TDF group), with a median time to onset of 104 weeks. |
| 2019-03-07 | ViiV Healthcare | Results ViiV HEALTHCARE PRESENTS POSITIVE, 48-WEEK DATA FROM TWO PIVOTAL PHASE III STUDIES SHOWING LONG-ACTING, INJECTABLE TWO-DRUG REGIMEN OF CABOTEGRAVIR AND RILPIVIRINE HAS SIMILAR EFFICACY TO DAILY, THREE-DRUG ORAL TREATMENT IN ADULTS LIVING WITH HIV-1 INFECTION viivhealthcare.com ↗
The study found virologic suppression rates (HIV-1 RNA <50 c/mL) at Week 48 were similar between treatment arms (cabotegravir + rilpivirine: 265/283 [93.6%], Triumeq: 264/283 [93.3%], adjusted difference: 0.4%. 95% CI: -3.7, 4.5). |
| 2017-10-20 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread® gilead.com ↗
In addition, updated results from two Phase 3 studies demonstrating improved long-term bone and renal safety in HBV-infected patients one year after switching from Viread ® (tenofovir disoproxil fumarate 300mg) to Vemlidy ® (tenofovir alafenamide 25mg) will be presented on October 21 . |
| 2016-03-01 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Second TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Odefsey ® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. |
All press releases naming this drug 4 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rifapentine | “A recent multi-centered, multi-national randomized control non inferiority trial with approximately 4,000 patients per arm demonstrated that Rifapentine and INH (3HP) given...” NCT02689089 ↗68“Once-weekly isoniazid and rifapentine for 3 months is a treatment option in persons with human immunodeficiency virus and latent tuberculosis infection.” PMID 29415190 ↗ Jul 2018 “8 weeks of daily isoniazid, rifapentine, moxifloxacin and pyrazinamide, followed by 9 weeks of daily isoniazid, rifapentine and moxifloxacin.” NCT07608172 ↗ “Oral chemoprophylaxis will be standard of care - either 6 months of Isoniazid or 3 months of weekly Isoniazid and Rifapentine” NCT05330884 ↗ “weekly oral Rifapentine 15 mg/kg (up to 900mg) plus Isoniazid 15 mg/kg (up to 900mg) for 12 doses” NCT02430259 ↗ “3H2P2 Regimen: Isoniazid (INH) + Rifapentine (RPT), twice weekly, 24 total doses (3 months)” NCT07811518 ↗ “daily rifapentine (R) and moxifloxacin (M) plus isoniazid (H) and pyrazinamide (P)” NCT05630872 ↗ “high-dose rifapentine (P), isoniazid (H), pyrazinamide (Z), and moxifloxacin (M)” NCT06153069 ↗ “Rifapentine (RPT) 900 mg once-weekly x 12 doses (3 months)” NCT00023452 ↗ “once-weekly rifapentine (RPT) and isoniazid (INH) (3HP)” NCT05122767 ↗ “Rifapentine” NCT02099240 ↗ |
| Known as | ANTIBIOTIC DL-473IT | ChEMBL registry synonym — accepted as the source's own label CHEMBL1660 ↗ |
| Known as | DL-473 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1660 ↗ |
| Known as | KTC-1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1660 ↗ |
| Known as | M000473 | “rifapentine (M000473)” NCT01690403 ↗ |
| Known as | MDL 473 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1660 ↗ |
| Known as | Prifitin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1660 ↗ |
| Known as | Priftin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1660 ↗ |
| Known as | Priftin - Rifapentine | “Priftin - Rifapentine” NCT00809718 ↗1“Priftin (rifapentine)” NCT02980016 ↗ |
| Known as | R-77-3 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1660 ↗ |
| Known as | Rifapentin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1660 ↗ |
| Known as | Rifapentina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1660 ↗ |
| Known as | Rifapentine RPT | “Rifapentine RPT” NCT03900858 ↗ |
| Known as | RPT | “3H2P2 Regimen: Isoniazid (INH) + Rifapentine (RPT), twice weekly, 24 total doses (3 months)” NCT07811518 ↗11“600 mg of Rifapentine (RPT) given once daily (o.d., omni die) for 6 weeks (6wP).” NCT03474029 ↗ “steady-state dolutegravir (DTG) and rifapentine (RPT) concentrations” NCT06281834 ↗ “escalating doses of rifapentine (RPT) administered daily by oral” NCT01162486 ↗ “once-weekly rifapentine (RPT) and isoniazid (INH) (3HP)” NCT05122767 ↗ “rifapentine (RPT, 900 mg)” NCT04600167 ↗ “Drug: Rifapentine (RPT)” NCT06917495 ↗ “Rifapentine (RPT)” NCT03886701 ↗ “Rifapentine (RPT)” NCT04272242 ↗ “Rifapentine (RPT)” NCT01404312 ↗ “Rifapentine (RPT)” NCT01574638 ↗ |
| Modality | Small molecule | — CHEMBL1660 ↗ |
| Route | Oral | “Rifapentine plus Isoniazid taken orally, weekly, by direct observation for 12 weeks” NCT00164450 ↗ |