This section highlights FDA-related milestones and regulatory updates for drugs developed by Hoth Therapeutics (HOTH).
Over the past two years, Hoth Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Glial, HT-001, HT-ALZ, and HT-KIT. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Glial Cell Line-Derived Neurotrophic Factor - FDA Regulatory Timeline and Events
Glial Cell Line-Derived Neurotrophic Factor is a drug developed by Hoth Therapeutics for the following indication: treatment for obesity.
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.
- Drug:
- Glial Cell Line-Derived Neurotrophic Factor
- Announced Date:
- March 4, 2025
- Indication:
- treatment for obesity
Announcement
Hoth Therapeutics, Inc. announced preclinical findings that highlight the potential of Glial Cell Line-Derived Neurotrophic Factor (GDNF) as a revolutionary treatment for obesity.
AI Summary
Hoth Therapeutics, Inc. announced promising preclinical findings on the potential of Glial Cell Line-Derived Neurotrophic Factor (GDNF) as a groundbreaking treatment for obesity. The research showed that GDNF helped reduce weight gain and fat buildup in animal models even when they were fed a high-fat diet. By boosting the metabolism, GDNF increased the body’s natural energy expenditure, leading to more fat burning without changing food intake.
The study also found that GDNF improved insulin sensitivity and glucose regulation while suppressing key genes involved in fat storage, which could lead to less fatty liver disease. These results suggest that GDNF might offer a novel approach to obesity treatment by activating the body’s inherent metabolic processes, rather than relying on appetite suppression. Hoth Therapeutics is now exploring various methods to develop this potential therapy further.
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HT-001 - FDA Regulatory Timeline and Events
HT-001 is a drug developed by Hoth Therapeutics for the following indication: Cancer patients suffering from cutaneous toxicities (skin, nails, scalp) due to EGFR.
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.
- Drug:
- HT-001
- Announced Date:
- June 24, 2025
- Indication:
- Cancer patients suffering from cutaneous toxicities (skin, nails, scalp) due to EGFR
Announcement
Hoth Therapeutics, Inc. announced that its investigational candidate HT-001 met the primary efficacy endpoint in at least one metric in 100% of patients in its ongoing Phase 2a clinical study (CLEER-001) evaluating treatment for epidermal growth factor receptor inhibitor (EGFRI)-induced cutaneous toxicities.
AI Summary
Hoth Therapeutics announced a promising result in its ongoing Phase 2a clinical study (CLEER-001) for HT-001, an investigational treatment for epidermal growth factor receptor inhibitor (EGFRI)-induced cutaneous toxicities. The data revealed that 100% of patients in the open-label cohort met at least one primary endpoint, showing clinical dermatologic improvement. This means that every patient experienced a measurable benefit from the treatment, which is significant for addressing the painful skin side effects often seen with EGFRI cancer therapies.
HT-001 is a once-daily topical gel that uses an FDA-approved neurokinin-1 receptor antagonist to help reduce inflammation and associated symptoms such as pain and itching. With these positive interim results, experts believe HT-001 could soon play an important role in improving quality of life for cancer patients who face dermatologic side effects from their treatments.
Read Announcement- Drug:
- HT-001
- Announced Date:
- June 5, 2025
- Indication:
- Cancer patients suffering from cutaneous toxicities (skin, nails, scalp) due to EGFR
Announcement
Hoth Therapeutics, Inc. announced a Key Opinion Leader (KOL) event showcasing HT-001, its novel topical therapeutic, designed to treat debilitating skin toxicities caused by EGFR inhibitor cancer therapies.
AI Summary
Hoth Therapeutics, Inc. is hosting a Key Opinion Leader (KOL) event to showcase its novel topical therapeutic, HT-001, designed to treat debilitating skin toxicities in cancer patients using EGFR inhibitors. These side effects, such as rashes and inflammation, can force patients to lower or stop vital cancer treatments. The event will present compelling clinical insights, including interim Phase 2a results that highlight HT-001’s strong safety profile and promising mechanism of action. Top derm-oncology and dermatology specialists, including Dr. Jonathan Hale Zippin and Dr. Adam Friedman, will discuss how HT-001 may offer a new standard of care, addressing a significant unmet need in oncology supportive care. The presentation will also detail the promising steps Hoth is taking toward protecting its intellectual property with new patent filings, positioning HT-001 as a potential breakthrough in managing cancer therapy-induced skin toxicities.
Read Announcement- Drug:
- HT-001
- Announced Date:
- April 15, 2025
- Indication:
- Cancer patients suffering from cutaneous toxicities (skin, nails, scalp) due to EGFR
Announcement
Hoth Therapeutics, Inc. announced positive interim data from the open-label portion of its Phase 2a clinical trial, CLEER-001, evaluating HT-001 for the treatment of pruritus associated with skin toxicities caused by Epidermal Growth Factor Receptor (EGFR) inhibitors.
AI Summary
Hoth Therapeutics recently announced promising interim results from the open‐label phase of its Phase 2a trial, CLEER‑001, which is evaluating HT‑001. This investigational topical treatment targets pruritus and skin toxicities caused by EGFR inhibitors used in cancer therapy. Interim data indicated a 50% reduction in itch severity over 21 days, with mean scores dropping from 1.6 on Day 1 to 0.8 on Day 21. Improvements were observed as early as Day 7, and some patients achieved complete symptom resolution.
HT‑001 was well tolerated, with no serious treatment‑related adverse events reported. These results highlight the potential of HT‑001 to relieve uncomfortable skin side effects, thus improving quality of life and treatment adherence for cancer patients. Continued evaluation in ongoing studies may further support its promise as a safe and effective remedy. These encouraging interim results mark an important step toward meeting an unmet need for patients undergoing cancer treatment.
Read Announcement- Drug:
- HT-001
- Announced Date:
- March 5, 2025
- Indication:
- Cancer patients suffering from cutaneous toxicities (skin, nails, scalp) due to EGFR
Announcement
Hoth Therapeutics Announced Positive Results for HT-001 in Treating EGFR Inhibitor-Associated Papulopustular Eruptions Findings to be Presented at the American Academy of Dermatology 2025 Annual Meeting
AI Summary
Hoth Therapeutics announced promising results for its novel HT-001 treatment to address papulopustular eruptions caused by EGFR inhibitors. In a recent case study, a 59-year-old metastatic breast cancer patient experienced severe skin reactions—pruritic, burning red papules on the face, scalp, and upper back—due to EGFR inhibitor therapy. After applying HT-001 2% cream twice daily for one week, the patient’s symptoms and lesions fully resolved, with no recurrence observed over the following three weeks.
The positive findings, which support HT-001 as a potential breakthrough therapy, will be presented at the American Academy of Dermatology 2025 Annual Meeting. As a topical neurokinin 1 receptor antagonist, HT-001 works by blocking the Substance P pathway, thus reducing inflammation and other skin toxicities associated with EGFR inhibitor treatment.
Read Announcement- Drug:
- HT-001
- Announced Date:
- January 7, 2025
- Indication:
- Cancer patients suffering from cutaneous toxicities (skin, nails, scalp) due to EGFR
Announcement
Hoth Therapeutics, Inc. today shared encouraging interim safety and efficacy results from its Phase 2a clinical trial of HT-001, designed to address skin toxicities linked to Epidermal Growth Factor Receptor Inhibitors (EGFRi) in cancer patients.
AI Summary
Hoth Therapeutics, Inc. announced promising interim results from its Phase 2a clinical trial of HT-001. The treatment is made to help cancer patients overcome skin toxicities caused by Epidermal Growth Factor Receptor Inhibitors (EGFRi). In the trial’s open-label portion, all patients in the first group achieved the main goal, reaching an ARIGA score of ≤1, which shows clear improvements in skin condition by the six-week mark. Moreover, 66% of patients experienced less pain and itching. Importantly, patients were able to keep their full EGFRi dosage, ensuring that the cancer treatments remained effective. The trial used a unique assessment scale, developed with expert help, to measure skin improvements accurately. These early results suggest that HT-001 might be a safe and effective option for reducing skin side effects without affecting the overall cancer care regimen.
Read Announcement- Drug:
- HT-001
- Announced Date:
- September 5, 2024
- Indication:
- Cancer patients suffering from cutaneous toxicities (skin, nails, scalp) due to EGFR
Announcement
Hoth Therapeutics, Inc announce positive data from the treatment of epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular eruptions (PPEs) with its novel therapeutic HT-001.
AI Summary
Hoth Therapeutics, Inc. announced positive data from its study on HT-001, a novel therapeutic for treating epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular eruptions (PPEs). In a first-of-its-kind human case, a 59-year-old female with metastatic breast cancer experienced rapid improvement. Within just one week of starting HT-001, the patient’s lesions resolved completely, and discomfort was significantly reduced. As a result, she discontinued the treatment after seven days, with no new lesions appearing over the following three weeks.
This breakthrough suggests that HT-001 may offer effective and safe relief from the cutaneous side effects commonly caused by EGFRI cancer treatments. PPEs can affect up to 90% of patients, often leading to severe discomfort and disruptions in their cancer therapy. The early success of HT-001 marks an important step toward improving the quality of life for patients experiencing these challenging skin toxicities.
Read Announcement- Drug:
- HT-001
- Announced Date:
- July 16, 2024
- Indication:
- Cancer patients suffering from cutaneous toxicities (skin, nails, scalp) due to EGFR
Announcement
Hoth Therapeutics, Inc. announced that it has received written approval from the GW University Hospital, UC Irvine and Northwell Health to proceed with its First-in-Human (FIH) Phase 2a clinical trial of HT-001 for the treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi).
AI Summary
Hoth Therapeutics, Inc. has received written approval from GW University Hospital, UC Irvine, and Northwell Health to begin its first-in-human Phase 2a clinical trial of HT-001. This trial will focus on treating skin toxicities caused by Epidermal Growth Factor Receptor Inhibitors (EGFRi) used in cancer treatment. The study is designed as a dose-ranging trial to assess the safety, tolerability, and efficacy of topical HT-001 in patients suffering from these skin-related side effects.
Hoth Therapeutics is hopeful that this trial will successfully deliver its lead therapeutic candidate, offering new hope for cancer patients experiencing uncomfortable skin conditions due to their treatment. The clinical trial marks an important step in the company’s efforts to improve patient quality of life by developing innovative treatment options, while also expanding the current treatment capabilities for skin toxicities associated with cancer therapies.
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HT-ALZ - FDA Regulatory Timeline and Events
HT-ALZ is a drug developed by Hoth Therapeutics for the following indication: Alzheimer's Disease.
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.
- Drug:
- HT-ALZ
- Announced Date:
- April 2, 2025
- Indication:
- Alzheimer's Disease
Announcement
Hoth Therapeutics, Inc. announced groundbreaking preclinical data supporting the therapeutic potential of its lead Alzheimer's candidate, HT-ALZ, in improving cognitive function and reducing neuroinflammation in Alzheimer's disease (AD).
AI Summary
Hoth Therapeutics has released groundbreaking preclinical data for its lead Alzheimer’s candidate, HT-ALZ, a formulation based on an FDA-approved NK-1 receptor antagonist. In studies using APP/PS1 mouse models of Alzheimer’s disease, HT-ALZ significantly improved cognitive function, including memory enhancement and reduced anxiety-like behavior, without affecting motor skills. A key finding was the marked reduction in GFAP-positive reactive astrocytes, which are linked to neuroinflammation and cognitive decline in AD. These results suggest that HT-ALZ not only improves Alzheimer’s symptoms but also targets the underlying neurodegeneration by modulating astrocyte activity. This dual-action profile, which impacts both the disease pathology and symptoms, offers a promising new approach in Alzheimer’s treatment. Hoth Therapeutics plans to advance HT-ALZ into clinical development as a potential first-in-class therapy for early-stage Alzheimer’s.
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HT-KIT - FDA Regulatory Timeline and Events
HT-KIT is a drug developed by Hoth Therapeutics for the following indication: Mast cell-derived cancers and anaphylaxis.
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.
- Drug:
- HT-KIT
- Announced Date:
- June 18, 2025
- Indication:
- Mast cell-derived cancers and anaphylaxis
Announcement
Hoth Therapeutics, announced encouraging preclinical results from a multi-dose study of HT-KIT, its investigational oncology candidate targeting the c-KIT pathway.
AI Summary
Hoth Therapeutics announced encouraging preclinical data for HT-KIT, its investigational oncology candidate aimed at the c-KIT pathway. In a multi-dose study, HT-KIT showed a clear dose-dependent increase in liver weight, indicating engagement with the target pathway, while no toxicity or adverse effects were observed in other organs like the kidney, spleen, or thymus. The study’s results, which showed normal organ weights and no visible lesions, confirm a clean safety profile for HT-KIT. These positive findings provide a strong safety signal and support the company’s plans to move forward with additional GLP toxicology studies and an Investigational New Drug (IND) submission. Hoth Therapeutics is encouraged by the data as it progresses HT-KIT further along the development path toward clinical trials.
Read Announcement- Drug:
- HT-KIT
- Announced Date:
- May 12, 2025
- Indication:
- Mast cell-derived cancers and anaphylaxis
Announcement
Hoth Therapeutics, Inc. announced compelling preclinical data for HT-KIT, its proprietary antisense oligonucleotide (ASO) therapeutic designed to target and silence aberrant KIT gene expression—implicated in a variety of rare, treatment-resistant cancers.
AI Summary
Hoth Therapeutics, Inc. has unveiled promising preclinical results for its innovative HT-KIT therapy, an antisense oligonucleotide designed to silence abnormal KIT gene expression. This gene is known to drive the growth of several treatment-resistant cancers. In laboratory studies, HT-KIT achieved over an 80% reduction in mutant KIT protein levels and significantly slowed tumor growth in models of gastrointestinal stromal tumors (GIST) and systemic mastocytosis. Notably, the treatment did not show any off-target toxicity in the liver, kidneys, or bone marrow, suggesting a strong safety profile. HT-KIT works by binding selectively to mutant KIT mRNA, blocking its translation and preventing the formation of the KIT protein. The company plans to submit an Investigational New Drug (IND) application to the FDA in early 2026, paving the way for first-in-human studies. This breakthrough offers a targeted approach for patients with rare, resistant KIT-mutated cancers.
Read Announcement- Drug:
- HT-KIT
- Announced Date:
- March 18, 2025
- Indication:
- Mast cell-derived cancers and anaphylaxis
Announcement
Hoth Therapeutics, Inc. announced breakthrough preclinical findings demonstrating the efficacy of HT-KIT, a novel targeted therapy for gastrointestinal stromal tumors (GIST). T
AI Summary
Hoth Therapeutics, Inc. recently announced breakthrough preclinical findings for its novel targeted therapy, HT-KIT, designed to treat gastrointestinal stromal tumors (GIST). The study showed that HT-KIT significantly reduces tumor growth by directly lowering KIT receptor expression, a key factor driving GIST progression. In lab tests, high doses of HT-KIT induced noticeable tumor cell death within 24 hours, while lower doses achieved similar effects by 72 hours. This therapy also curtailed cell proliferation in GIST-T1 cells, resulting in reduced tumor sizes. In humanized mouse models, the treatment led to statistically significant decreases in tumor growth as early as day 8, with excised tumors being smaller and lighter compared to controls. By specifically targeting KIT mutations, HT-KIT holds promise for overcoming resistance to current treatments and offers a new hope for patients battling this aggressive form of cancer.
Read Announcement- Drug:
- HT-KIT
- Announced Date:
- August 15, 2024
- Indication:
- Mast cell-derived cancers and anaphylaxis
Announcement
Hoth Therapeutics, Inc. announced that it has entered into a Master Services Agreement with Aronnax, Inc. for its HT-KIT cancer therapeutic.
AI Summary
Hoth Therapeutics, Inc. announced a new Master Services Agreement with Aronnax, Inc. to advance its cancer therapeutic HT-KIT. This antisense oligonucleotide targets the KIT receptor, which is critical for mast cell survival, and has shown promise in preclinical studies examining its effectiveness against mast cell-derived cancers and conditions like anaphylaxis.
Under the agreement, Aronnax will manage ITR Laboratories to conduct a study focused on defining the maximum-tolerated dose (MTD) through intravenous injections. The study involves a dose range-finding phase where different dosing groups are evaluated, with a 48-hour period between each group. This work will provide essential dosing metrics to guide the design of future clinical trials, moving HT-KIT closer to serving patients in need.
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