Drugs / ibalizumab
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed multidrug-resistant tuberculosis 1 milestone | |||||
| Filed | Other | Trogarzo® | multidrug-resistant tuberculosis | 2025-12-04 | “has officially submitted the registration dossier for TaiMed's innovative HIV therapy Trogarzo® (ibalizumab) to the Saudi Food and Drug Authority (SFDA)” taimedbiologics.com ↗ |
| Withdrawn Indication not stated 4 milestones | |||||
| Withdrawn | EU (EMA) | Trogarzo | — | 2023-01-01 | europa.eu ↗ |
| Label expansion | US (FDA) | TROGARZO | — | 2022-10-03 | fda.gov ↗ |
| Approved | EU (EMA) | Trogarzo | — | 2019-09-26 | europa.eu ↗ |
| Approved | US (FDA) | TROGARZO | — | 2018-03-06 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01292174 | Feb 2011 → Sep 2012 | — | TaiMed Biologics Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01056393 | Nov 2009 → Dec 2016 | HIV infectious disease | Kaiser Permanente | Completed | No outcome recorded |
| Phase 2 | NCT00089700 | Mar 2004 → ? | HIV infectious disease | Tanox | Unknown | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT03913195 | May 2019 → Oct 2022 | HIV infectious disease | TaiMed Biologics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02707861 | Mar 2016 → Nov 2018 | HIV infectious disease | TaiMed Biologics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02475629 | Aug 2015 → Oct 2016 | HIV infectious disease | TaiMed Biologics Inc. | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT02028819 | Jan 2012 → Feb 2014 | HIV infectious disease | University of Colorado, Denver | No longer available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT00784147 Comparator | Aug 2008 → Apr 2011 | HIV infectious disease | TaiMed Biologics Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-07-06 | TaiMed Biologics Inc. | Regulatory TaiMed Biologics (4147) Receives TFDA Drug License Collection Notice for Trogarzo, Marking the Final Step Toward Commercial Launch in Taiwan taimedbiologics.com ↗
TaiMed Biologics (TPEX: 4147) announced today that its HIV therapy Trogarzo (ibalizumab; English name: Trogarzo Injection; Chinese name: 佐加洛注射劑) has officially received a Drug License Collection Notice from the Taiwan Food and Drug Administration (TFDA). |
| 2026-06-01 | TaiMed Biologics Inc. | Regulatory TaiMed Biologics (4147) Achieves Key Milestone for Trogarzo Launch in Taiwan; Partner Orient Pharma (4120) Secures TFDA Name Approval taimedbiologics.com ↗
Its commercialization partner, Orient Pharma Co., Ltd. (“Orient Pharma”; TPEX: 4120), has received an Approval Letter from the Taiwan Food and Drug Administration (TFDA), formally approving the English and Chinese product names for Trogarzo. |
| 2025-12-04 | TaiMed Biologics Inc. | Regulatory TaiMed Biologics (4147) Announces its Marketing Partner AcedrA BioPharmaceuticals Submitted registration dossier for the biological product Trogarzo® to the Saudi Food and Drug Authority(SFDA) taimedbiologics.com ↗
TaiMed Biologics (TPEX: 4147) announced today that its marketing partner, AcedrA BioPharmaceuticals, has officially submitted the registration dossier for TaiMed's innovative HIV therapy Trogarzo® (ibalizumab) to the Saudi Food and Drug Authority (SFDA) . |
| 2025-10-20 | TaiMed Biologics Inc. | Regulatory Saudi Food and Drug Authority (SFDA) Grants Orphan Drug Designation to TaiMed Biologics' HIV treatment, Trogarzo - a Monoclonal Antibody for Multidrug-Resistant HIV-1 Infection taimedbiologics.com ↗
This recognition marks a significant regulatory milestone, as Trogarzo received Orphan Drug Designation. |
| 2025-04-02 | TaiMed Biologics Inc. | Regulatory Macau Pharmaceutical Administration Bureau Approves TaiMed Bologics’ Trogarzo as the First and Only Monoclonal Antibody for the Treatment of HIV taimedbiologics.com ↗
TaiMed Biologics is proud to announce that Macau Pharmaceutical Administration Bureau approves Trogarzo Biological License Application (BLA) per the notice from Wuzhou Drug International Trading Co., Ltd., (hereinafter called “WUZHOU”). |
| 2025-03-13 | TaiMed Biologics Inc. | Results TaiMed marketing partner, Theratechnologies Inc announcement of presentation from Virologic Suppression Data from the PROMISE-US Trial of Ibalizumab at CROI taimedbiologics.com ↗
TaiMed marketing partner, Theratechnologies Inc. today presented data from a real-world, observational, registry study demonstrating the efficacy and safety of ibalizumab in reducing HIV RNA to undetectable levels in heavily treatment-experienced (HTE) patients with multidrug resistant HIV. |
All press releases naming this drug 18 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ibalizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01056393 ↗ |
| Known as | HU5A8 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743029 ↗ |
| Known as | ibalizumab-uiyk | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03913195 ↗ |
| Known as | TNX-355 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00089700 ↗ |
| Known as | Trogarzo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743029 ↗ |
| Action | Inhibit | “suppresses HIV replication by blocking entry of HIV into CD4+ lymphocytes” NCT02028819 ↗ |
| Modality | Monoclonal antibody | “ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion” NCT00784147 ↗ |
| Route | Intravenous | “intravenous infusions of TNX-355, 15 mg/kg” NCT00089700 ↗ |
| Target | CD4 | “directed against a human T-cell receptor (CD4)” NCT02028819 ↗ |