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Is panacea biotech dengue trial completed?

Asked by CNI Follower · 3 months ago · 13-12-2025

Panacea Biotec’s dengue vaccine trial is not yet fully completed.

Current status as of December 2025:

- The candidate vaccine is DengiAll, a tetravalent, single‑dose dengue vaccine developed by Panacea Biotec in collaboration with ICMR. (economictimes.indiatimes.com)

- Phase I/II trials in India were completed earlier (around 2018–2020) with acceptable safety data. (hindustantimes.com)

- The Phase III clinical trial:

- Was initiated in August 2024 across ~19–20 sites in India, with a target of about 10,300–10,500 participants. (newindianexpress.com)

- As per ICMR updates in July 2025, enrolment was ongoing, with about 8,000 participants dosed and enrolment expected to be completed by October 2025. (business-standard.com)

- Each participant will be followed for around two years to assess efficacy and safety before final data submission to CDSCO/DCGI. (hindustantimes.com)

Implication for you as an investor:

- By late 2025, Phase III enrolment is likely completed or near completion, but:

- Full trial completion (including 2‑year follow‑up and final analysis) is still pending.

- There is no DCGI marketing approval yet; no licensed dengue vaccine from Panacea Biotec is commercially available in India at this point. (economictimes.indiatimes.com)

So, the company has crossed early‑stage risk (Phase I/II done) and is in the late-stage (Phase III, follow‑up and data-readout phase), but the dengue program cannot yet be treated as “completed” in regulatory/commercial terms.

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