Drugs / Hypericin
Hypericin
also known as
HIPERICIN · HIPERICIN BATCH 867911 MS 1.1860.0003.003-0 · HyBryte · HYPERICIN SODIUM · Hypericina · Hypericine · Hypericum red · NSC-407313 · +1 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | HyBryte | primary cutaneous T-cell lymphoma | 2023-02-14 | “FDA has provided the Company with a Refusal to File (RTF) letter for its HyBryte ™ (synthetic hypericin) new drug application (NDA)” soligenix.com ↗ |
| Filed | US (FDA) | HyBryte | primary cutaneous T-cell lymphoma | 2022-12-15 | “submitted a new drug application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for HyBryte” soligenix.com ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00000792 | ? → Jan 1995 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00000645 | ? → Oct 1994 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06149247 | Dec 2023 → May 2024 | mycosis fungoides | Soligenix | Completed | No outcome recorded |
| Phase 2 | NCT05872854 | Aug 2023 → Dec 2025 | mycosis fungoides | Ellen Kim, MD | Completed | No outcome recorded |
| Phase 2 | NCT05442190 | Dec 2022 → Oct 2025 | psoriasis | Soligenix | Completed | No outcome recorded |
| Phase 2 | NCT05380635 | May → Aug 2022 | mycosis fungoides | Soligenix | Completed | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT06470451 | Jan 2025 → May 2026 | mycosis fungoides | Soligenix | Terminated | Missed primary |
| Phase 3 | NCT01365676 | Mar → Oct 2012 | premenstrual tension, uterine disorder | Phytopharm Consulting Brazil | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT02448381 Comparator | Dec 2015 → Jun 2020 | primary cutaneous T-cell lymphoma | Soligenix | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 32
| Date | Issuer | Release |
|---|---|---|
| 2026-04-28 | Soligenix | Results Soligenix Announces Interim Results from the Phase 3 FLASH2 Trial Evaluating HyBryte™ in Treatment of Cutaneous T-Cell Lymphoma soligenix.com ↗
Under the terms of the interim analysis, the study was recommended to halt for futility. |
| 2026-04-02 | Soligenix | Results Positive Clinical Results from HyBryte™ Comparative Study Evaluating HyBryte™ Against Valchlor® in the Treatment of Cutaneous T-Cell Lymphoma Published in Oncology and Therapy soligenix.com ↗
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the positive results of its comparability study evaluating HyBryte™ (synthetic hypericin) versus Valchlor ® (mechlorethamine) for the treatment of cutaneous T-cell lymphoma (CTCL) have been published in Oncology and Therapy . |
| 2026-03-19 | Soligenix | Results Soligenix Announces HyBryte™ Clinical Summary Published in "Expert Opinion on Investigational Drugs" soligenix.com ↗ |
| 2025-12-17 | Soligenix | Results Soligenix Announces Top-line Results of the Phase 2a Study of SGX302 (Synthetic Hypericin) in Patients with Mild-to-Moderate Psoriasis soligenix.com ↗
One patient achieved a disease status of "Almost Clear" using the IGA, which is considered a standard clinical measure for treatment success in psoriasis , with a substantial improvement in their PASI score, exceeding 50%. |
| 2025-10-07 | Soligenix | Results Soligenix Achieves Important Safety Milestone in its Confirmatory Phase 3 Clinical Trial of HyBryte™ for the Treatment of Cutaneous T-Cell Lymphoma soligenix.com ↗
there are no safety concerns with the ongoing Phase 3 study |
| 2025-04-14 | Soligenix | Results Positive Outcome in 75% of CTCL Patients Treated with HyBryte™ for 18 Weeks soligenix.com ↗
Following 18 weeks of treatment, 75% of patients achieved "Treatment Success," reinforcing HyBryte™ as a potentially safe and fast-acting therapy for this chronic and underserved cancer. |
| 2025-01-14 | Soligenix | Results HyBryte™ Expanded Treatment Continues to Demonstrate Positive Outcomes in Early-Stage Cutaneous T-Cell Lymphoma soligenix.com ↗
Patients have responded positively to HyBryte™ therapy, with over 70% (5 of the 6 subjects who have completed at least 18 weeks of therapy) already achieving "Treatment Success". |
| 2024-12-02 | Soligenix | Results HyBryte™ Clinical Results Demonstrate Continued Improvement Post-Treatment soligenix.com ↗
No such instances were reported in the HyBryte™ group. |
| 2024-10-07 | Soligenix | Results HyBryte™ Expanded Treatment Results to be Presented at the European Organisation for Research and Treatment of Cancer Conference soligenix.com ↗
Two Presentations Highlight HyBryte™ Therapy's Improved Response Rates with Extended Treatment and Increased Light Doses |
| 2024-07-09 | Soligenix | Results Expanded HyBryte™ Treatment Demonstrating Positive Outcomes in Early-Stage Cutaneous T-Cell Lymphoma soligenix.com ↗
Patients have responded positively to HyBryte™ therapy with 75% (3 of the 4 subjects who have completed at least 12 weeks of therapy) already achieving "Treatment Success", as predefined in the study's protocol as ≥50% improvement in their cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to Baseline. |
| 2024-06-25 | Soligenix | Results Soligenix Announces Positive Clinical Results from a Comparative Study Evaluating HyBryte™ Against Valchlor® in the Treatment of Cutaneous T-Cell Lymphoma soligenix.com ↗
The study revealed that HyBryte™ treatment resulted in 60% of patients achieving a 50% or better improvement in their mCAILS score versus 20% of Valchlor ® patients, with HyBryte™ having a more favorable safety profile. |
| 2024-05-16 | Soligenix | Results Positive Clinical Results from HyBryte™ Compatibility Study in the Treatment of Cutaneous T-Cell Lymphoma Published in JEADV Clinical Practice soligenix.com ↗
The publication highlights the positive clinical results from study, HPN-CTCL-02, evaluating HyBryte™ in the treatment of CTCL. |
| 2024-01-04 | Soligenix | Results Soligenix Announces Top-line Results of the Phase 2a Study of SGX302 (Synthetic Hypericin) in Patients with Mild-to-Moderate Psoriasis soligenix.com ↗
In addition, the Psoriasis Activity and Severity Index (PASI) score, another well-characterized measure of treatment success, for patients in Cohort 2 had a mean drop of approximately 50% over the 18-week treatment. |
| 2023-07-11 | Soligenix | Results Soligenix Announces Expansion of SGX302 (Synthetic Hypericin) Phase 2a Study in Mild-to-Moderate Psoriasis soligenix.com ↗
Evaluation of the initial five subjects enrolled demonstrated a clear biological signal, with the majority of patients recording an improvement in the PASI (psoriasis area and severity index) score. |
| 2023-05-04 | Soligenix | Results Soligenix Announces Positive Clinical Results from Compatibility Study of HyBryte™ in the Treatment of Cutaneous T-Cell Lymphoma soligenix.com ↗
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive clinical results from a compatibility study evaluating HyBryte™ (synthetic hypericin sodium) in the treatment of cutaneous T-cell lymphoma (CTCL) using the commercially ready Daavlin Series 7 visible light device, which recently received 510(k) clearance from U.S. Food and Drug Administration (FDA). |
| 2023-04-05 | Soligenix | Regulatory Soligenix Receives USAN Approval for "Hypericin Sodium" as Nonproprietary Name for Novel Active Ingredient in HyBryte™ and SGX302 soligenix.com ↗ |
| 2023-02-14 | Soligenix | Regulatory Soligenix Receives Refusal to File Letter from U.S. FDA for HyBryte™ New Drug Application in the Treatment of Cutaneous T-Cell Lymphoma soligenix.com ↗ |
| 2022-12-15 | Soligenix | Regulatory Soligenix Announces Submission of New Drug Application to the FDA for HyBryte™ in the Treatment of Cutaneous T-cell Lymphoma soligenix.com ↗ |
| 2022-07-27 | Soligenix | Regulatory Soligenix Receives Agreement from FDA on Initial Pediatric Study Plan for HyBryte™ for the Treatment of Cutaneous T-Cell Lymphoma soligenix.com ↗
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received agreement from the US Food & Drug Administration (FDA) on an initial pediatric study plan (iPSP) for HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL). |
| 2022-07-20 | Soligenix | Results HyBryte™ Phase 3 FLASH Study for the Treatment of Cutaneous T-Cell Lymphoma Published in JAMA Dermatology soligenix.com ↗
Published findings demonstrate that HyBryte ™ treatment statistically significantly reduced CTCL lesion size |
| 2022-06-28 | Soligenix | Regulatory Soligenix Receives FDA IND Clearance for Phase 2 Clinical Trial of Synthetic Hypericin in the Treatment of Psoriasis soligenix.com ↗
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 2a clinical trial titled, " Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis ." |
| 2021-11-08 | Soligenix | Regulatory Soligenix Granted Pediatric Investigational Plan Waiver for HyBryte™ in CTCL in the United Kingdom soligenix.com ↗
The waiver was provided for all subsets of the pediatric population from birth to less than 18 years of age on the grounds that clinical studies in this rare population are not feasible. |
| 2021-09-09 | Soligenix | Regulatory FDA Grants Soligenix Orphan Drug Designation for the Treatment of T-cell Lymphoma soligenix.com ↗ |
| 2021-06-10 | Soligenix | Regulatory Soligenix Receives Pediatric Investigational Plan Waiver for HyBryte™ in CTCL from the European Medicines Agency soligenix.com ↗
announced today that it has received a Pediatric Investigation Plan (PIP) waiver from the European Medicines Agency (EMA) for HyBryte™ (SGX301 or hypericin) |
| 2021-05-10 | Soligenix | Regulatory HyBryte™ Awarded Innovation Passport in the United Kingdom soligenix.com ↗
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that HyBryte™ (hypericin) was awarded an "Innovation Passport" for the treatment of early stage cutaneous T-cell lymphoma (CTCL) in adults under the United Kingdom's (UK's) Innovative Licensing and Access Pathway (ILAP). |
| 2021-05-04 | Soligenix | Results Broad Efficacy and Improved Safety Profile of HyBryte™ Presented at Society for Investigative Dermatology Virtual Meeting soligenix.com ↗
The presentation was selected to be shown during a Concurrent Mini-Symposium for Patient-Targeted Research. |
| 2021-04-26 | Soligenix | Results HyBryte™ Expanded Efficacy and Safety Data Presented at the American Academy of Dermatology Meeting soligenix.com ↗
Compared to other, second-line, approved drugs for the treatment of CTCL, this response rate was shown to be as good or better than other treatments, with significantly less safety concerns. |
| 2021-04-07 | Soligenix | Regulatory Soligenix Receives Conditional FDA Acceptance of Proposed Brand Name HyBryte™ for SGX301 in CTCL soligenix.com ↗
announced today that the U.S. Food and Drug Administration (FDA) has conditionally accepted HyBryte™ as the proposed brand name for SGX301 (synthetic hypericin), the Company's novel first-in-class photodynamic therapy for first-line treatment of early stage cutaneous T-cell lymphoma (CTCL). |
| 2020-10-22 | Soligenix | Results Soligenix Announces Phase 3 FLASH Study Continues to Demonstrate Positive Benefits in Patients with Cutaneous T-Cell Lymphoma soligenix.com ↗
SGX301 continued to be very well tolerated, benefiting from the lack of hypericin circulation in the blood stream after targeted topical application to the lesions, as well as the use of visible light. |
| 2020-04-30 | Soligenix | Results Soligenix Announces Positive Phase 3 FLASH Study Demonstrates Increased Efficacy with Continued Treatment in Patients with Cutaneous T-Cell Lymphoma soligenix.com ↗
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that continued treatment with SGX301 (synthetic hypericin) twice weekly for 12 weeks increased the positive response rate to 40% (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment) in the open-label treatment cycle (referred to as Cycle 2) of its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study for the treatment of early-stage cutaneous T-cell lymphoma (CTCL). |
| 2020-03-19 | Soligenix | Results Soligenix Announces Positive Top-line Results for its Pivotal Phase 3 FLASH Trial Evaluating SGX301 in Treatment of Cutaneous T-Cell Lymphoma soligenix.com ↗
The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. |
| 2017-02-02 | Soligenix | Regulatory Soligenix Announces SGX301 Receives Promising Innovative Medicine Designation from the UK Medicines and Healthcare Products Regulatory Agency soligenix.com ↗
announced today SGX301 (synthetic hypericin) has been granted Promising Innovative Medicine (PIM) designation in the United Kingdom (UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of cutaneous T-cell lymphoma (CTCL). |
All press releases naming this drug 64 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Hypericin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05442190 ↗ |
| Known as | HIPERICIN | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01365676 ↗ |
| Known as | HIPERICIN BATCH 867911 MS 1.1860.0003.003-0 | “HIPERICIN® BATCH 867911 MS 1.1860.0003.003-0” NCT01365676 ↗ |
| Known as | HyBryte | “HyBryte” NCT05872854 ↗ |
| Known as | HYPERICIN SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL286494 ↗ |
| Known as | Hypericina | ChEMBL registry synonym — accepted as the source's own label CHEMBL286494 ↗ |
| Known as | Hypericine | ChEMBL registry synonym — accepted as the source's own label CHEMBL286494 ↗ |
| Known as | Hypericum red | ChEMBL registry synonym — accepted as the source's own label CHEMBL286494 ↗ |
| Known as | NSC-407313 | ChEMBL registry synonym — accepted as the source's own label CHEMBL286494 ↗ |
| Known as | SGX301 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02448381 ↗ |
| Modality | Traditional medicine (herbal / TCM) | “2 phytomedicines already in the market: GAMALINE® for premenstrual syndrome and HIPERICIN® as antidepressant will be prescribed together for treating women with Premenstrual...” NCT01365676 ↗ |
| Route | Intravenous | “receives a given dose of hypericin by intravenous infusion” NCT00000645 ↗ |