Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 153 |
| INN | Ibalizumab |
| Status | Approved |
| Drug code(s) | TMB-355, TNX-355, HU-5A8 |
| Brand name | Trogarzo |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD4 |
| Indications of clinical studies | HIV Infections |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Approved EU, US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2001 |
| Start of Phase 2 | May 15, 2004 |
| Start of Phase 3 | August 15, 2015 |
| Date BLA/NDA submitted to FDA | May 03, 2017 |
| Year of first approval (global) | 2018 |
| Date of first US approval | March 06, 2018 |
| INN, US product name | Ibalizumab, Ibalizumab-uiyk |
| US or EU approved indications | Chronic HIV infection in patients who have not responded adequately to other treatments |
| Company | Genentech |
| Licensee/Partner | TaiMed Biologics Inc. |
| Comments about company or candidate | Approved March 6, 2018 in US; approved in EU in Sep 2019 September 26, 2019 I Theratechnologies Inc. is pleased to announce that Trogarzo® (ibalizumab) was approved today by the European Commission. July 2019: CHMP issued a positive opinion; approval may follow with 67 days. September 14, 2018 – Theratechnologies Inc. is pleased to announce that the European Medicines Agency (“EMA”) has confirmed the validity of the marketing authorization application for Trogarzo™ (ibalizumab) filed on August 28, 2018. The validation confirms the submission is complete, and begins the EMA’s centralized review process. As a result, the start of procedure date has been set to September 13, 2018. The EMA will review the application for Trogarzo™ under the accelerated assessment procedure. PDUFA date is April 3, 2018 (extended from Jan 3). BLA granted a priority review. May 3, 2017: TaiMed Biologics completed submission of BLA. NCT02475629 Phase 3 study recruiting as of Aug 2015. Breakthrough therapy designation granted in March 2015; also has orphan drug designation. TMB-355 caught the attention of the scientific community in February 2003, when results from the phase-1, single-dose clinical trial showed a transient but clinically significant reduction in the patients’ viral load. The U.S. FDA granted TMB-355 fast track status in October 2003. The phase-2a clinical trial was successfully completed in 2006, with the results showing a clean safety profile and clear antiviral activity (10-fold reduction in viral load). The Phase-2b clinical trial was also successfully completed in 2011. TaiMed Biologics developed a subcutaneous injection dosage form and a phase 1 human pharmacokinetics bridging study is completed in 2012. The company is now working on a 2nd-generation version of the mAb. US orphan status granted in Oct 2014; The Phase II trial of ibalizumab in treatment-experienced patients infected with HIV-1 is currently recruiting participants. The trial was verified in April 2014 by its sponsor, Kaiser Permanente. 5A8 in preclinical development in Tanox pipeline as of Feb 2000. |
| Full address of company | South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us |
The IgG4 heavy chain hinge region sequence is not modified to prevent formation of half antibodies.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |