drugset

Drugs / INI-2004

Follow last change Apr 2026 re-read 3 minutes ago

INI-2004

targets TLR4 via activation

Developed for: allergic rhinitis · ragweed sensitivity
Investigated by: Avance Clinical Pty Ltd. · Inimmune Corporation

Trials 1

today NCT06038279 · Ph 1

202420252026

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT06038279	Jul 2023 → Sep 2024	allergic rhinitis, ragweed sensitivity	Inimmune Corporation	Completed	No outcome recorded
Comparator or background therapy1 trial
Phase 2	NCT07556393 Comparator	Jan → Apr 2026	allergic rhinitis	Inimmune Corporation	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 2

Date	Issuer	Release
2025-02-26	Inimmune Corporation	Results Inimmune to present successful Phase I allergy trial results at the American Academy of Allergy Asthma & Immunology meeting in San Diego, February 28-March 3, 2025 inimmune.com ↗ In response to the ragweed challenge, participants in our Phase I study treated with INI-2004 intranasally showed a dose-dependent improvement in nasal congestion as measured by acoustic rhinometry compared to placebo participants.
2024-05-15	Inimmune Corporation	Results Inimmune Announces Successful Phase 1 Clinical Results For Disease Modifying Allergy Treatment, INI-2004 inimmune.com ↗ Inimmune, a leading clinical stage biotech company focused on the development of novel vaccine adjuvants, immunotherapies and delivery systems, announced today the top line results from its Phase 1b Multiple Ascending Dose (MAD) study of INI-2004 in people suffering with Allergic Rhinitis (NCT06038279).

All press releases naming this drug 6 releases

Date	Issuer	Release
2026-03-12	Inimmune Corporation	Inimmune Completes Enrollment and Doses First Patient in Phase 2 Chamber Trial of INI-2004 for Allergic Rhinitis inimmune.com ↗
2026-03-05	Inimmune Corporation	Inimmune Strengthens Leadership Team Ahead of Phase 2 INI-2004 Allergic Rhinitis Data Readout inimmune.com ↗
2026-01-07	Inimmune Corporation	Inimmune Commences Pivotal Phase 2 Allergy Trial of INI-2004 in Allergic Rhinitis Patients inimmune.com ↗
2025-02-26	Inimmune Corporation	Inimmune to present successful Phase I allergy trial results at the American Academy of Allergy Asthma & Immunology meeting in San Diego, February 28-March 3, 2025 inimmune.com ↗
2024-05-15	Inimmune Corporation	Inimmune Announces Successful Phase 1 Clinical Results For Disease Modifying Allergy Treatment, INI-2004 inimmune.com ↗
2023-08-02	Inimmune Corporation	Inimmune Corporation announces First Subject Dosed in First-in-Human Phase 1 Clinical Trial of its novel intranasal TLR4 agonist, INI-2004, for the Treatment of Allergic Rhinitis and FDA Clearance of IND application for INI-2004 inimmune.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

Field	Value	Cited text
Known as	INI-2004	ClinicalTrials.gov intervention name — accepted as the source's own label NCT06038279 ↗ 1 NCT07556393 ↗
Action	Activate	“TLR4 agonist” NCT06038279 ↗
Route	Intranasal	“INI-2004 is an intranasal (IN) TLR4 agonist” NCT06038279 ↗
Target	TLR4	“INI-2004 is an intranasal (IN) TLR4 agonist” NCT06038279 ↗