Ainos (AIMD) FDA Approvals

Ainos' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Ainos (AIMD). Over the past two years, Ainos has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as VELDONA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

VELDONA FDA Regulatory Timeline and Events

VELDONA is a drug developed by Ainos for the following indication: Potential Treatment of Oral Warts in HIV-Seropositive. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Approved - August 4,2025

Taiwan's Food and Drug Administration (TFDA)

• Drug: VELDONA
• Announced Date: August 4, 2025
• Indication: Potential Treatment of Oral Warts in HIV-Seropositive

Ainos, Inc. announced that its investigational low-dose oral interferon-alpha drug candidate, VELDONA®, has received formal approval from Taiwan's Food and Drug Administration (TFDA) to initiate a clinical study for primary Sjögren's syndrome (pSS).

Ainos, Inc., a Texas-based AI and biotech company, announced that its oral interferon-alpha candidate VELDONA® has received approval from Taiwan’s Food and Drug Administration (TFDA) to begin an open-label study for primary Sjögren’s syndrome (pSS).

The trial, titled “An open-label study to evaluate the efficacy of VELDONA® in patients with primary Sjögren’s Syndrome” (Study No. 24PSS01), will be run at Taipei Medical University–Shuang Ho Hospital. Patient enrollment begins in October 2025 and will span six months.

ComboTrial Consultancy Ltd., a TFDA-certified and GCP-compliant organization, will oversee clinical operations and monitoring. The study is expected to finish in the first half of 2027.

VELDONA® is designed to modulate the immune system with a low-dose oral interferon-alpha formulation. Early research has shown it can improve dryness symptoms in pSS without serious side effects, offering hope for patients with this chronic autoimmune condition.

Provided Update - April 14,2025

• Drug: VELDONA
• Announced Date: April 14, 2025
• Indication: Potential Treatment of Oral Warts in HIV-Seropositive

Ainos, Inc. announced significant progress in advancing its oral interferon drug platform, VELDONA® in the rare disease space.

Ainos, Inc. has made significant progress in advancing its oral interferon drug platform, VELDONA®, in the rare disease space. The company is moving forward with clinical trials in Taiwan using a new formulation of VELDONA® to treat HIV-related oral warts and primary Sjögren’s Syndrome. The Taiwan Food and Drug Administration has approved its trial for HIV-related oral warts, and the Institutional Review Board has cleared the study for Sjögren’s Syndrome. These trials aim to show that the new formulation is as effective or better than earlier results, and may help speed up the approval process in the United States and Taiwan.

Ainos is also planning bridging consultations with both the FDA and TFDA. This strategic approach could lead to a harmonized regulatory process, potentially accelerating market entry. The company’s partnership with Taiwan Tanabe Seiyaku further supports its efforts to bring a convenient, non-invasive treatment option to patients with limited therapeutic alternatives.

Foreign Approval - September 25,2024

• Drug: VELDONA
• Announced Date: September 25, 2024
• Indication: Potential Treatment of Oral Warts in HIV-Seropositive

Ainos, Inc. announced it has received Institutional Review Board (IRB) approval from the National Taiwan University Hospital for its clinical trial focused on treating oral warts in HIV-positive patients.

Ainos, Inc. has received Institutional Review Board (IRB) approval from National Taiwan University Hospital to start a clinical trial aimed at treating oral warts in HIV-positive patients. The study will assess the efficacy of VELDONA®, a low-dose oral interferon formulation, by comparing its effects to a placebo. The trial will be conducted at a single site, enrolling 40 HIV-positive individuals who are currently on combination antiretroviral therapy. Participants will take 10 sublingual tablets daily for a 24-week period. This important step demonstrates the company’s commitment to addressing the quality of life issues faced by HIV-positive patients who suffer from oral warts. While IRB approval marks a significant milestone, the company now awaits further clearance from Taiwan’s Food and Drug Administration to officially commence the study, with patient enrollment expected to begin soon.

Regulatory Update - September 23,2024

• Drug: VELDONA
• Announced Date: September 23, 2024
• Target Action Date: Q4 2024
• Estimated Target Date Range: October 1, 2024 - December 31, 2024
• Indication: Potential Treatment of Oral Warts in HIV-Seropositive

Ainos, Inc. announced that Ainos aims to complete all regulatory approvals for the study in Q4 2024

Ainos, Inc. recently announced plans for an upcoming clinical study in Taiwan to evaluate the effectiveness of very low-dose interferon alpha (VELDONA) for treating Sjögren’s syndrome. This new study, set to take place at Taipei Medical University-Shuang Ho Hospital, will assess how well the treatment improves saliva production and reduces dryness symptoms in patients.

A key highlight of the announcement is that Ainos aims to finalize all necessary regulatory approvals by Q4 2024. After completing these approvals, the study is scheduled to begin with a site initiation meeting and the first patient visit in December 2024. The trial will involve patients taking three sublingual tablets daily for a period ranging from 24 to 48 weeks, marking an important step in the company’s efforts to advance treatment options for Sjögren’s syndrome.

Provided Update - September 23,2024

• Drug: VELDONA
• Announced Date: September 23, 2024
• Indication: Potential Treatment of Oral Warts in HIV-Seropositive

Ainos, Inc. announce that it plans to conduct a Taiwan clinical study for very low-dose interferon alpha (VELDONA) on treating Sjögren's syndrome at Taipei Medical University-Shuang Ho Hospital.

Ainos, Inc. has announced plans to conduct a clinical study in Taiwan that will test its very low-dose interferon alpha treatment, VELDONA, for treating Sjögren's syndrome. The study will take place at Taipei Medical University-Shuang Ho Hospital, with the Allergy, Immunology, and Rheumatology Department leading the effort. The trial will involve 24 patients who are expected to take three sublingual tablets of VELDONA daily for 24 to 48 weeks. The main goal is to assess how effectively the treatment improves saliva production and reduces dryness symptoms associated with primary Sjögren's syndrome. Secondary objectives include evaluating changes in standardized dryness and disease activity scores, as well as monitoring improvements in oral and ocular discomfort. The clinical trial is managed by a locally certified organization, with regulatory approvals expected to be completed by November 2024 and study initiation planned for December 2024.

Provided Update - September 20,2024

• Drug: VELDONA
• Announced Date: September 20, 2024
• Indication: Potential Treatment of Oral Warts in HIV-Seropositive

Ainos, Inc. announced that Water Tower Research ("WTR") has issued a note on the Company's upcoming clinical trial for VELDONA®, a low-dose oral interferon-alpha formulation, in treating oral warts in HIV+ patients on antiretroviral therapy ("ART").

Ainos, Inc. announced that Water Tower Research (WTR) has issued a note on its upcoming clinical trial for VELDONA®, a low-dose oral interferon‐alpha formulation. The clinical trial will evaluate the effectiveness of VELDONA® in treating oral warts in HIV+ patients who are on antiretroviral therapy (ART). The study is designed as a single-site, double-blind trial set to begin at National Taiwan University Hospital by November 2024. It will enroll 40 subjects, with participants randomly assigned in a 3:1 ratio to receive either VELDONA® or a placebo. The main goal of the trial is to achieve at least a 75% reduction in the surface area of oral warts over a 24‑week period. This trial reflects Ainos’ focus on cost-efficient clinical research and its commitment to addressing an unmet medical need among HIV+ patients.

Clinical Study - September 17,2024

• Drug: VELDONA
• Announced Date: September 17, 2024
• Indication: Potential Treatment of Oral Warts in HIV-Seropositive

Ainos, Inc. is pleased to announce that its plans to initiate a clinical study for very low-dose interferon alpha (VELDONA) on treating Human immunodeficiency virus (HIV)-related oral warts at the National Taiwan University Hospital.

Ainos, Inc. announced plans to start a clinical study at National Taiwan University Hospital to test its very low-dose interferon alpha formulation, VELDONA®, for treating HIV-related oral warts. This study is set to be conducted at one of Taiwan’s top medical centers for HIV care, where nearly 4,000 HIV-positive patients receive treatment.

The trial will enroll 40 participants who will be randomly assigned in a double-blind setup to receive either VELDONA® or a placebo over a 24‐week period. The main goal is to see if VELDONA® can reduce the surface area of oral warts by at least 75% compared to the baseline. Secondary outcomes include a 50% reduction and patient-reported improvements in oral health. The study highlights new hope for HIV-positive individuals struggling with oral warts as it aims to provide an effective treatment option.

Dose Update - July 23,2024

• Drug: VELDONA
• Announced Date: July 23, 2024
• Target Action Date: July 26, 2024
• Indication: Potential Treatment of Oral Warts in HIV-Seropositive

Ainos, Inc. announced that Dosing of the first subject is expected to occur on July 26, 2024.

Ainos, Inc. announced a key milestone in its clinical trial of a VELDONA-based animal drug. The company expects to dose the first subject on July 26, 2024. This trial, conducted in Taiwan, is designed as a randomized, double-blind, parallel, single-center study to evaluate the safety, tolerability, and efficacy of low-dose oral interferon in treating feline chronic gingivostomatitis, a painful oral disease in cats. The study will enroll 30 subjects, with plans to complete enrollment by the end of 2024. A trial report is anticipated in the first quarter of 2025. If the results are promising, Ainos intends to apply for an animal drug certificate from Taiwan’s regulatory authorities. This development marks an important step forward in the company’s efforts to create innovative treatment options for pet health challenges.

Enrollment Update - July 23,2024

• Drug: VELDONA
• Announced Date: July 23, 2024
• Indication: Potential Treatment of Oral Warts in HIV-Seropositive

Ainos, Inc announced it has enrolled the first subject for its Taiwanese clinical study of VELDONA®-based animal drug in treating feline chronic gingivostomatitis ("FCGS"), a serious and painful chronic cat oral disease characterized by inflammation or abnormal proliferation in the oral cavity

Ainos, Inc. recently announced a significant milestone by enrolling the first subject in its Taiwanese clinical trial of a VELDONA®-based animal drug designed to treat feline chronic gingivostomatitis (FCGS). FCGS is a severe, painful oral disease in cats marked by significant inflammation and abnormal tissue growth, which often leads to chronic discomfort. The study is designed as a randomized, double-blind, parallel, single-center, multiple-dose trial aimed at assessing the safety, tolerability, and effectiveness of low-dose oral interferon alpha for this condition. Dosing for the first subject is scheduled for July 26, 2024, with plans to complete the enrollment of 30 subjects by the end of 2024. The final trial report is expected in the first quarter of 2025, reflecting Ainos’s commitment to advancing treatment options for pets suffering from FCGS.