Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 70

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 70
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 applicable FDA or other requirements may result in refusal to approve pending applications,
imposition of clinical holds on ongoing trials, warning letters, civil or criminal penalties, recall or seizure of products, partial or
total suspension of production or distribution, or withdrawal of the product from the market. FDA approval is required before any new
drug, including any new indication for a previously approved drug, can be marketed in the United States.

The steps required before a drug may be marketed
in the United States generally include the following:

●completion of extensive preclinical laboratory tests, potentially including animal studies, and formulation studies in accordance
with the FDA’s good laboratory practice (“GLP”) regulations and other applicable regulations;

●submission to the FDA of an IND to support human clinical testing, which must become effective before human clinical trials may begin;

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●approval from the DEA prior to commencement of any clinical trials in the United States that involve the use of Schedule I controlled
substances, which would include our lead drug candidates, IHL-42X, PSX-001 and IHL- 675A;

●authorization from an independent institutional review board (“IRB”) or ethics committee at each clinical trial site before
each clinical trial may be initiated;

●performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practice
(“GCP”) requirements, and other clinical-trial related regulations to establish the safety and efficacy of the investigational
drug for each proposed indication;

●submission to the FDA of an NDA for marketing approval, including payment of application user fees;

●satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the API and finished
drug product are produced and tested to assess compliance with cGMP requirements to assure that the facilities, methods and controls are
adequate to preserve the product’s identity, strength, quality and purity;

●potential FDA audit of the clinical trial sites to assure compliance with IND regulations and GCP requirements and to assure the integrity
of the clinical data submitted in support of the NDA;

●satisfactory completion of an FDA advisory committee review, if applicable; and

●FDA review and approval of the NDA/Biologics Licensing Application and DEA scheduling (for a controlled substance) prior to any commercial
marketing or sale of the drug in the United States.

Clinical Development

Before any drug candidate may be tested in humans,
it must undergo rigorous preclinical testing. Preclinical tests generally include laboratory evaluations of a drug