Company: SHPH
Filing Date: 2025-02-27
Form Type: 424B3
Source: 0001493152-25-008478
Chunk: 7

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-27
Form: 424B3
Chunk 7
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 tumor cancer indications. Our pipeline is represented in the diagram below:

Timeline for our clinical phase (Ropidoxuridine) and pre-clinical phase (HDAC inhibitors) pipeline.

Our lead product candidates include:

| ● | Ropidoxuridine                                                                                                                              
 (IPdR) is our lead candidate radiation sensitizer for use in combination with RT to                                                         
 treat brain tumors (glioblastoma) and sarcomas. Phase I clinical trial results supported by an NIH contract to Shuttle Pharma and           
 the NCI (CTEP) were reported in the medical journal, Clinical Cancer Research, in July 2019, by our SBIR subcontractor. Eighteen            
 patients completed dose escalations to 1,800 mg/day for 30 days, establishing the maximum tolerated dose (MTD) of 1,200 mg/day in           
 combination with RT. Four partial responses, nine stable disease and one progressive disease in target lesions were reported. Four          
 patients did not have measurable disease and, as a result, were not evaluable. These Phase I trial results demonstrate oral bioavailability 
 and an MTD of 1,200 mg per day for 28 days for use in combination with radiation for Phase II clinical trials that we proposed to           
 perform in brain tumors and in sarcomas. The brain tumor, glioblastoma multiforme (GB) is eligible for orphan disease designations.         
 Shuttle Pharma has advanced drug manufacture and formulation and prepared a clinical protocol of a “Phase 2 Single-Arm Study                
 of IPdR as a Radiation Sensitizing Agent During Radiotherapy in Patients with Newly Diagnosed IDH-Wildtype MGMT Unmethylated Glioblastoma   
 Multiforme.” In December 2023, we submitted an IND application with the FDA to support the next phase of development of Ropidoxuridine.     
 In January 2024, we received the ‘Safe to Proceed’ letter from the FDA for our IND application for the Phase II study                       
 of Ropidoxuridine (IPdR) as a radiation sensitizing agent during radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma    
 with unmethylated MGMT promoter. Receipt of the letter allows us to commence the Phase II study of Ropidoxuridine (IPdR). The clinical      
 development of Ropidoxuridine has shown drug bioavailability and a maximum tolerated dose has been established for use in Phase II