Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 73

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 73
---
 specified disease or condition to identify
possible adverse side effects and safety risks and to evaluate the preliminary efficacy, optimal dosages and dosing schedule. Multiple
Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

●Phase 3: The investigational product is administered to an expanded patient population in adequate and well-controlled studies to
further evaluate dosage, clinical efficacy and safety, generally at multiple geographically dispersed clinical trial sites. These clinical
trials are intended to establish the overall risk/benefit relationship of the investigational product and to provide, if appropriate,
an adequate basis for product labeling. These trials may include comparisons with placebo and/or other comparator treatments. The duration
of treatment is often extended to mimic the actual use of a product during marketing.

●Phase 4: Additional trials may be conducted after initial marketing approval. These trials are used to gain additional experience
from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance of Phase
4 clinical trials as a condition of approval of an NDA.

Concurrent with clinical trials, sponsors usually
complete additional nonclinical studies and must also develop additional information about the product and finalize a process for manufacturing
the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing
quality batches of the drug candidate and, among other things, the manufacturer must develop and validate methods for testing the identity,
strength, quality and purity of the final product. Moreover, appropriate packaging must be selected and tested, and stability studies
must be conducted to assure product integrity and demonstrate that the drug candidate does not undergo unacceptable deterioration over
its shelf life.

Congress recently amended the FDCA, as part of
the Consolidated Appropriations Act for 2023, in order to require sponsors of a Phase 3 clinical trial, or other “pivotal study”
of a new drug to support marketing authorization, to design and submit a diversity action plan for such clinical trial. The action plan
must include the sponsor’s diversity goals for enrollment, as well as a rationale for the goals and a description of how the sponsor
will meet them. Sponsors must submit a diversity action plan to the FDA by the time the sponsor submits the relevant clinical trial protocol
to the agency for review. As of the time of this filing, there is uncertainty as to what the specific requirements pertaining to a diversity
action plan may be. The FDA may grant a waiver