Drugs / RELUSCOVTOGENE RALAPLASMID
RELUSCOVTOGENE RALAPLASMID
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | COVID-19 | 2021-11-09 | “INOVIO's INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800, in the U.S. The FDA has lifted the partial clinical hold” inovio.com ↗ |
| Clinical hold | US (FDA) | — | COVID-19 | 2020-09-28 | “Until the FDA's questions have been satisfactorily addressed, INOVIO's Investigational New Drug Application (IND) for the Phase 2/3 trial is on partial clinical hold” inovio.com ↗ “The Phase 3 segment of the INNOVATE trial in the U.S. remains on partial clinical hold until INOVIO satisfactorily resolves the FDA's remaining questions” inovio.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05430958 | Oct 2022 → Mar 2024 | COVID-19 | Inovio Pharmaceuticals | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT04336410 | Apr 2020 → Feb 2022 | COVID-19 | Inovio Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04447781 | Jul 2020 → Jul 2021 | COVID-19 | International Vaccine Institute | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04642638 | Nov 2020 → Sep 2022 | COVID-19 | Inovio Pharmaceuticals | Terminated | Mixed Stop: Business |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2022-05-10 | Inovio Pharmaceuticals | Results INOVIO Reports First Quarter 2022 Financial Results and Program Developments inovio.com ↗
Reports, with partner Advaccine, positive T cell immune response data with INO-4800 as a heterologous booster to an inactivated COVID-19 vaccine |
| 2021-11-09 | Inovio Pharmaceuticals | Regulatory INOVIO Reports Third Quarter 2021 Financial Results inovio.com ↗
INOVIO announced that the U.S. Food and Drug Administration (FDA) provided authorization to proceed for INOVIO's INNOVATE Phase 3 segment for its COVID-19 vaccine candidate, INO-4800, in the U.S. |
| 2021-11-09 | Inovio Pharmaceuticals | Regulatory INOVIO Receives U.S. FDA Authorization to Proceed with INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800, in the U.S. inovio.com ↗
The FDA has lifted the partial clinical hold following the FDA's review of additional non-clinical, clinical, and device information provided by INOVIO. |
| 2021-11-03 | Inovio Pharmaceuticals | Regulatory INOVIO Further Expands INNOVATE Phase 3 Trial for COVID-19 DNA Vaccine Candidate INO-4800 With Regulatory Authorization from India inovio.com ↗
Regulatory authorization in India follows authorizations from health authorities in Brazil , Philippines , Mexico and Colombia . |
| 2021-10-12 | Inovio Pharmaceuticals | Results INOVIO Announces Online Preprint Publication of Homologous Boosting Data for its COVID-19 DNA Vaccine Candidate, INO-4800 inovio.com ↗ |
| 2021-10-11 | Inovio Pharmaceuticals | Regulatory INOVIO Expands INNOVATE Phase 3 for INO-4800, its DNA Vaccine Candidate for COVID-19, to include Colombia following Regulatory Authorization inovio.com ↗ |
| 2021-09-22 | Inovio Pharmaceuticals | Regulatory INOVIO Receives Regulatory Authorization to Conduct Phase 3 Efficacy Trial of its COVID-19 DNA Vaccine Candidate, INO-4800, in Mexico inovio.com ↗ |
| 2021-08-26 | Inovio Pharmaceuticals | Regulatory INOVIO Receives Authorization to Conduct Phase 3 Efficacy Trial of its COVID-19 DNA Vaccine Candidate, INO-4800 inovio.com ↗
INOVIO's global Phase 3 efficacy trial receives authorization to proceed from Brazil; other countries to follow INOVIO to conduct INNOVATE Phase 3 efficacy trial with partner Advaccine in areas of world in need of COVID-19 vaccines |
| 2021-08-09 | Inovio Pharmaceuticals | Regulatory INOVIO and Advaccine Receive Regulatory Allowance for Two Heterologous Prime-Boost Clinical Trials in China Using INO-4800, INOVIO's COVID-19 DNA Vaccine Candidate inovio.com ↗
China's Center for Drug Evaluation of the National Medical Products Administration has allowed the initiation of two Advaccine-sponsored open-label, positive-control trials to evaluate the safety, tolerability, and immunogenicity of mixed boosted regimens. |
| 2021-05-10 | Inovio Pharmaceuticals | Results INOVIO Announces Positive Data from Phase 2 Segment of Clinical Trial Evaluating INO-4800, its COVID-19 DNA Vaccine inovio.com ↗
INO-4800 was shown to be safe, well-tolerated and immunogenic in all age groups |
| 2021-04-15 | Inovio Pharmaceuticals | Results INOVIO's COVID-19 Vaccine Candidate, INO-4800, Provides Broad Cross-reactive Immune Responses In Humans Against Variants of Concern inovio.com ↗
The results showed that INO-4800 induced a robust T cell response against all spike protein variants tested, which the company believes will be key in providing protection against SARS-CoV-2 variants, in addition to providing similar levels of neutralizing activity against both the UK and Brazilian variants as those against the original strain. |
| 2020-12-24 | Inovio Pharmaceuticals | Results INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet's EClinicalMedicine inovio.com ↗ |
| 2020-11-16 | Inovio Pharmaceuticals | Regulatory INOVIO Announces Initiation of Phase 2 Segment of its Phase 2/3 Clinical Trial for its COVID-19 DNA Vaccine Candidate, INO-4800; Trial Will Be Funded by the U.S. Department of Defense inovio.com ↗ |
| 2020-09-28 | Inovio Pharmaceuticals | Regulatory INOVIO Reports FDA Partial Clinical Hold for Planned Phase 2 / 3 Trial of COVID-19 Vaccine Candidate INO-4800 inovio.com ↗
Until the FDA's questions have been satisfactorily addressed, INOVIO's Investigational New Drug Application (IND) for the Phase 2/3 trial is on partial clinical hold. |
| 2020-07-30 | Inovio Pharmaceuticals | Results INOVIO's COVID-19 DNA Vaccine INO-4800 Provides Protection with Memory Immune Responses In Non-Human Primates Challenged with SARS-CoV-2 Virus inovio.com ↗
These protective results were mediated by memory T and B cell immune responses from INO-4800 vaccination. |
| 2020-06-30 | Inovio Pharmaceuticals | Results INOVIO Announces Positive Interim Phase 1 Data For INO-4800 Vaccine for COVID-19 inovio.com ↗ |
| 2020-05-20 | Inovio Pharmaceuticals | Results INOVIO's COVID-19 DNA Vaccine INO-4800 Demonstrates Robust Neutralizing Antibody and T Cell Immune Responses in Preclinical Models inovio.com ↗
INOVIO (NASDAQ:INO) today announced the publication of the preclinical study data for IN0-4800, its COVID-19 DNA vaccine, demonstrating robust neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2. |
| 2020-04-06 | Inovio Pharmaceuticals | Regulatory INOVIO Initiates Phase 1 Clinical Trial Of Its COVID-19 Vaccine and Plans First Dose Today inovio.com ↗
The first dosing is planned for today. |
All press releases naming this drug 30 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RELUSCOVTOGENE RALAPLASMID | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095348 ↗ |
| Known as | INO-4800 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04336410 ↗ |
| Known as | PGX-9501 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095348 ↗ |
| Modality | Vaccine | “an investigational DNA vaccine (INO-4800) targeting full-length spike antigen” PMID 35079784 ↗ Jun 2022 |
| Route | Other | “INO-4800 administered by intradermal (ID) injection followed by electroporation (EP)” NCT04447781 ↗ |