A Phase 2a Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, of HBI-002, an Oral Low-dose Carbon Monoxide (CO) Liquid Drug Product, Administered Daily Over 14 Days in Subjects With Parkinson's Disease (PD)

A phase 2a multicenter, randomized, double-blind, placebo-controlled multiple dose study to evaluate the safety, tolerability, pharmacokinetics, of HBI-002, an oral low-dose carbon monoxide (CO) liquid drug product, administered daily over 14 days in subjects with Parkinson's disease (PD).

开始日期2026-06-30

申办/合作机构

Hillhurst Biopharmaceuticals, Inc.

[+1]

NCT07129590

/ RecruitingN/AIIT

TRauma-Informed Care in Smoking cEssation for Pregnancy (RISE Pregnancy)

Trauma-informed approaches have been shown to support recovery from other substance use disorders and involve four key elements: (1) Realizing the prevalence of trauma and pathways to recovery, (2) Recognizing symptoms of trauma, (3) Responding by embedding knowledge of trauma into practices and policies and (4) Resisting re-traumatization (the 4Rs). In close partnership with Breathe California and a public safety-net clinic in San Francisco that serves primarily racial and ethnic minoritized (REM) pregnant women, the 4Rs along with the Ask, Advise, Assess, Assist and Arrange (the 5As) evidence-based intervention for tobacco cessation that is delivered by health care professionals and is a US Public Health Services clinical practice guideline for treating tobacco will be used to create and implement a smoking cessation intervention for pregnant women with experiences of trauma.

开始日期2025-11-19

申办/合作机构

The University of California, San Francisco

NCT06763536

/ RecruitingN/AIIT

Testing Oral Nicotine Pouches to Reduce Smoking-Related Cancer in Rural Appalachia

This clinical trial compares the use of oral nicotine pouches to nicotine replacement therapy, consisting of nicotine patches and lozenges, to reduce cigarette use in smokers living in rural Appalachia. The lung and oral cancers that plague Appalachia are fueled by cigarette smoking. Oral nicotine pouches which contain nicotine but no tobacco leaf, present a new opportunity to reduce cancer risk among Appalachian adults who smoke. Oral nicotine pouches and nicotine replacement therapy may work well to reduce cigarette use for smokers in rural Appalachia.

开始日期2025-06-13

申办/合作机构

Ohio State University Comprehensive Cancer Center

[+1]

100 项与 HBI-002 相关的临床结果

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100 项与 HBI-002 相关的转化医学

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100 项与 HBI-002 相关的专利（医药）

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1,342

项与 HBI-002 相关的文献（医药）

2026-10-01·NEUROCHEMISTRY INTERNATIONAL

Mild traumatic brain injury produces persistent wake-state instability and EEG slowing despite carbon monoxide neuroprotection

Article

作者: Voltarelli, Vanessa A ; Fuller, Patrick M ; Gallo, David ; Weber, Janick ; Meehan, William P ; Alves de Souza, Rodrigo W ; Broadhurst, Rebecca Y ; Otterbein, Leo E

Individuals who experience mild traumatic brain injury (mTBI) frequently report persistent sleep-wake disturbances that impair daytime function and recovery. However, the physiological nature of these disturbances remains incompletely understood. Using a closed-head lateral-impact model of single and repeated mTBI in mice, we examined the acute and chronic effects of injury on EEG activity and behavioral state organization. Although mTBI did not alter the total amount of time spent awake or asleep, both single and repeated injuries produced a marked and persistent fragmentation of wakefulness that remained evident for up to 12 weeks after injury. Spectral analysis further revealed increased low-theta (4-8 Hz) activity during wakefulness, consistent with reduced cortical activation and impaired arousal stability. Because low concentrations of carbon monoxide (CO) have been reported to exert neuroprotective effects in models of brain injury, we also examined whether inhaled CO could mitigate these abnormalities. While CO reduced acute injury-associated measures and glial stress marker expression, it did not rescue wake fragmentation or EEG spectral changes at the time points tested. Together, these findings identify persistent wake-state instability as a key consequence of mTBI and suggest that mechanisms governing the maintenance of consolidated wakefulness remain disrupted despite attenuation of acute injury-related pathology.

2026-09-01·Medical Gas Research

Research and application of gas therapy in preventing biofilm associated infections

Review

作者: Wang, Yadi ; Li, Xueling ; Lü, Junhong ; Yang, Pan

Conventional antibiotic therapies often fail to eradicate biofilms, which can lead to persistent infections and significant clinical challenges. Gas therapy, which utilizes the unique properties of gas molecules such as nitric oxide, carbon monoxide, hydrogen, and hydrogen sulfide, is emerging as a promising and innovative strategy to address these challenges. This review first highlights gas signaling in bacterial biofilms. It then goes on to list four types of gas therapy in detail: photothermal-enhanced gas therapy, photodynamic-activated gas therapy, micro/nanobubble-mediated gas therapy, and gas-based synergistic therapy. Their potential applications and future directions are also fully discussed. Due to its unique bioactivity, low resistance, and synergy with existing treatments, gas therapy has demonstrated significant potential in the prevention and treatment of biofilm-associated infections. However, overcoming delivery challenges, validating efficacy in large-scale trials, and developing standardized protocols are essential for its clinical translation. Future efforts should prioritize the integration of nanotechnology and mechanistic studies to unlock broader therapeutic utility.

2026-08-01·CYTOKINE

Systemic delivery of carbon monoxide by CORM-401 mitigates inflammation and alveolar bone loss in a rat model of periodontitis

Article

作者: Motterlini, Roberto ; Carnio, Evelin C ; Foresti, Roberta ; Solon, Isabelly G ; Branco, Luiz G S ; Santos, Wanderson S ; Lopes, Pedro H ; Emilio-Silva, Maycon T

BACKGROUND:

Periodontitis is a chronic inflammatory disease characterized by excessive production of pro-inflammatory mediators, oxidative stress, and extracellular matrix degradation, ultimately leading to alveolar bone loss. Carbon monoxide (CO), an endogenous gasotransmitter produced during heme degradation, exhibits anti-inflammatory, antioxidant, and cytoprotective properties. CORM-401, an orally active CO-releasing molecule, can deliver CO systemically with high efficiency, and its ability to regulate energetic metabolism, reduce inflammation, and limit oxidative stress has been documented. However, its potential therapeutic effects in the treatment of periodontal disease have never been investigated.

OBJECTIVE:

To evaluate whether orally administered CORM-401 attenuates alveolar bone loss and gingival inflammation in a rat model of ligature-induced periodontitis.

METHODS:

Adult rats were subjected to ligature placement of the first molar to induce periodontitis and treated orally with CORM-401 or vehicle. Alveolar bone loss was quantified by CEJ-BC measurements. Gingival tissues were analyzed for cytokines (TNF-α and IL-1β), nitric oxide metabolites (NOx), and MMP-2 activity. Systemic inflammation was assessed by measuring plasma TNF-α.

RESULTS:

CORM-401 significantly reduced alveolar bone loss compared with vehicle-treated periodontitis rats. Treatment markedly decreased gingival levels of TNF-α and IL-1β. CORM-401 also reduced gingival NOx accumulation, indicating attenuation of oxidative and proteolytic stress. Plasma TNF-α was lower in CORM-401-treated animals, demonstrating a systemic anti-inflammatory effect.

CONCLUSION:

Oral administration of CORM-401 effectively mitigates periodontal inflammation and protects against alveolar bone loss in ligature-induced periodontitis. These findings suggest that CO-based pharmacological modulation may represent a promising host-directed therapeutic strategy for controlling periodontal tissue destruction.

项与 HBI-002 相关的新闻（医药）

2026-06-15

·PRNewswire

Hillhurst Bio Doses First Subject in Phase 2a Clinical Trial of HBI-002, a Novel Therapy for Parkinson's Disease

SAN DIEGO, June 15, 2026 /PRNewswire/ -- Hillhurst Biopharmaceuticals Inc. ("Hillhurst Bio"), a clinical-stage biopharmaceutical company focused on developing novel oral liquid drug products based on known inhaled therapeutics, today announced that the first subject has been dosed in its Phase 2a clinical trial evaluating HBI-002 for the treatment of Parkinson's disease. This trial is supported by funding from The Michael J. Fox Foundation for Parkinson's Research (MJFF), as part of its Therapeutics Pipeline Program, and the Farmer Family Foundation. The therapeutic rationale for HBI-002 stems from long-standing epidemiological evidence indicating up to a 60% lower relative risk of developing Parkinson's disease among cigarette smokers and is supported by preclinical data showing neuroprotection with HBI-002. This research is distinct from and does not mitigate the well-established health risks associated with smoking. "Dosing the first subject in this study marks a significant milestone," said Chief Executive Officer Andrew Gomperts. "There remains a substantial unmet medical need for therapies that address the underlying patho-biology of Parkinson's disease, and we are hopeful that our novel drug product can provide benefits to patients. The first readout is expected by the end of 2026." This Phase 2a clinical trial for HBI-002 is a blinded, randomized, controlled study designed to assess the safety and tolerability of HBI-002 in people with Parkinson's disease. Biomarker and pharmacokinetic data will also be collected to provide preliminary insights into the investigational therapy's potential efficacy. Data from this study will inform the design of the larger Phase 2b clinical trial, planned to begin in 2027. About Parkinson's Disease: Parkinson's disease is a progressive neurodegenerative disorder that affects movement and a range of non-motor functions. While current treatments help manage symptoms, there remains a need for therapies that address the underlying biology of the disease. Parkinson's disease affects approximately 1.1 million people in the United States. About HBI-002: HBI-002 is Hillhurst Bio's lead investigational product candidate, an oral low-dose carbon monoxide (CO) drug designed for chronic use in a home setting by patients with Parkinson's disease. In addition to Parkinson's disease, other potential indications for HBI-002 include conditions associated with inflammation and cell death, such as sickle cell disease. A Phase 1 clinical study in healthy subjects under an Investigational New Drug (IND) application has been successfully completed. About Hillhurst: Hillhurst Bio is a clinical-stage company focused on its proprietary GLASS™ platform, which enables the development of novel drug products based on known inhaled therapeutics . The platform overcomes limitations of traditional inhaled delivery methods and includes a unique pipeline of liquid therapeutic candidates aimed at treating sickle cell disease, Parkinson's disease, and acute pain. SOURCE Hillhurst Biopharmaceuticals, Inc. 21% more press release views with Request a Demo

临床2期临床1期

2026-04-10

·化学经纬

新系列氮配体实现Ullmann反应新突破

N1,N2-二芳基苯-1,2-二胺配体 N1,N2-diarylbenzene-1,2-diamine ligands C-N键、C-O键是药物和材料中常见的C-杂原子键，通过钯催化的偶联反应构建已经非常成熟，但是钯金属价格高，在工业生产过程中增加成本。传统的铜催化Ullmann型偶联反应，能够避免贵金属钯的使用。但目前已报道的大部分反应体系，反应温度高，部分体系反应温度超过100 ℃，反应条件复杂，限制了其在复杂底物上的应用。本文将介绍一类N1,N2-二芳基苯-1,2-二胺配体，可实现温和条件下C-N键、C-O键的构建。 2023年，Stephen L. Buchwald小组首次报到了阴离子N1,N2-二芳基苯-1,2-二胺配体的设计开发及应用。这些配体需：1) 增加铜上的电子密度，从而提高芳基溴化物氧化加成的速率；2) 通过π相互作用稳定活性阴离子CuI络合物。在优化条件下，使用配体L4，可实现铜催化芳基和杂芳基溴化物胺化。同时，包括含有多个官能团的药物在内的多种烷基胺亲核试剂，均可在室温下高效偶联。计算和实验研究相结合表明，通过修饰配体结构引入萘基残基，降低了氧化加成的能垒，使反应速率比其他配体提高了30倍。铜与阴离子配体配位后催化的反应机理与钯催化的C-N偶联反应类似。在这些体系中，氧化加成之后依次发生胺的结合和去质子化，以及还原消除，最终生成胺化产物。相反，采用电荷中性配体的铜基体系通常在氧化加成之前发生胺的结合/去质子化，这可能是这些体系在烷基胺和芳基卤化物偶联反应中效率普遍较低的原因。 2024年，Stephen L. Buchwald小组报道了N1,N2-二芳基苯-1,2-二胺配体L8应用于铜催化芳基及杂芳基溴化物与醇的C−O偶联，与前述用于C−N偶联的配体L4反应体系相比，L8衍生的催化剂表现出更高的活性，尤其是在对含有酸性官能团的芳基溴化物进行官能化时。机理研究表明，利用L8·Cu进行的C−O偶联反应涉及速率控制步骤——醇盐金属转移，其C−O键的形成机理与之前报道的钯、铜或镍基体系截然不同。这种低能途径能够实现快速的C−O键形成，其反应速率比其他配体提高了7倍。同年，Stephen L. Buchwald小组还报道了L8配体用于铜催化胺化。该体系官能团耐受性强，适用于碱敏感的芳基溴化物，包括含有酸性官能团和小五元杂芳环的底物。阴离子型N1,N2-二芳基苯-1,2-二胺配体L8与温和碱NaOTMS的组合，可形成一种稳定且活性高的催化剂，该催化剂能够抵抗因与杂环或带电中间体配位而导致的失活。该体系催化剂和配体用量较低。利用Cu·L8催化的C-O和C-N偶联反应中亲核试剂去质子化的差异，还能化学选择性地对多种氨基醇底物进行N-和O-芳基化。当氨基醇含有伯醇和位阻较大的胺基或苯胺基时，以叔丁醇钠(NaOt-Bu)为碱，仅发生C-O偶联。而使用NaOTMS则能够完全克服这些反应的空间位阻选择性，无论氨基醇的结构如何，均能选择性地促进C-N偶联。 2024年，Stephen L. Buchwald小组还报道了一种温和的铜催化芳基氯化物胺化方法。使用位阻极大的N1,N2-二芳基苯-1,2-二胺配体L5，该配体能够抵抗催化剂失活，而使反应能够在显著降低的温度下进行，并且适用范围比现有方法更广。该方法已成功应用于(杂)芳基氯化物与多种结构各异的胺的C-N偶联反应。多种源自药物的复杂芳基氯化物和胺类化合物均能高效偶联反应。机理研究表明，铜催化剂对芳基氯化物的氧化加成是速率控制步骤。 2025年，Stephen L. Buchwald小组进一步报道了三氟甲基取代的N1,N2-二芳基苯-1,2-二胺配体L6应用于铜催化碱敏感的芳基氯化物和胺类化合物发生偶联反应。 DFT计算表明：1)甲基取代基引起的空间位阻导致构象变化，从而为配体去质子化和氧化加成提供了额外的空间；2)三氟甲基基团在配体和芳基氯化物底物之间形成静电相互作用，促进了通过空间配体-底物相互作用进行的氧化加成反应。 2026年，Stephen L. Buchwald小组报道了对N1,N2-二芳基苯-1,2-二胺配体进一步优化的配体L15，该配体增强铜中心的路易斯酸性，从而可以使用比之前体系(NaOMe或NaOt-Bu)中所需的碱温和得多的碱(NaOTMS或NaOPh)。在优化的反应条件下，几种先前不相容的芳基溴化物均能高效转化，包括碱敏感杂环化合物和含有酸性官能团的化合物。动力学分析表明，C-O偶联是通过醇亲核试剂的结合/去质子化机制进行的，碱的pKa值影响总反应速率，并且可以使用亚化学计量的强碱来加速配体活化，从而提高总反应速率。本文介绍了一系列基于N1,N2-二芳基苯-1,2-二胺配体骨架的氮配体，成功实现了温和条件下铜催化的C-N和C-O键高效构建。通过增加铜中心电子密度、利用π相互作用稳定活性物种以及引入空间位阻和静电调控等，所开发的配体体系（如L4、L5、L6、L8、L15等）可显著降低氧化加成或金属转移步骤的能垒，使反应速率极大的提升。这一系列的催化体系在室温下即可实现结构多样的芳基溴化物、芳基氯化物与烷基胺及醇类的高效偶联，对含酸性官能团、杂环及药物分子等复杂底物表现出优异的耐受性。为铜催化C-杂原子键形成反应提供了兼具普适性与可调性的配体平台。本文转载：上海毕得公众号

2025-07-23

·PRNewswire

Hillhurst Biopharmaceuticals Doses First Subject in Phase 2a Clinical Trial of HBI-002, a Novel Therapy for Sickle Cell Disease

SAN DIEGO, July 23, 2025 /PRNewswire/ -- Hillhurst Biopharmaceuticals Inc. ("Hillhurst"), a clinical-stage biopharmaceutical company focused on developing novel oral liquid drug products based on known inhaled therapeutics, today announced that the first subject has been dosed in its Phase 2a clinical trial evaluating HBI-002 for the treatment of sickle cell disease. "Dosing the first subject marks a significant milestone," said co-founder and Chief Executive Officer Andrew Gomperts. "There remains a substantial unmet medical need in preventing the painful vaso-occlusive crises experienced by sickle cell patients. We are hopeful that our novel drug product can provide meaningful relief for patients and their families. We look forward to advancing with this trial and expect the first readout by the end of 2025." The Phase 2a clinical trial for HBI-002, an oral low-dose carbon monoxide (CO) therapeutic candidate, is an open-label study designed to assess the safety and tolerability of HBI-002 in patients with sickle cell disease. The trial will also collect biomarker and pharmacokinetic data, providing preliminary insights into the investigational therapy's potential efficacy. Data from this study will inform the design of the larger Phase 2b clinical trial, planned to begin in 2026. About Sickle Cell Disease: Sickle cell disease (SCD) is a genetic disorder that causes severe vaso-occlusive pain crises and is associated with serious clinical consequences, including stroke, heart disease, kidney disease, and premature death. The average life expectancy of SCD patients in the U.S. is only 45 years, underscoring the urgent need for more effective treatments. About HBI-002: HBI-002 is Hillhurst's lead product candidate, an oral low-dose carbon monoxide (CO) investigational drug designed for chronic use in a home setting by patients with sickle cell disease. Other potential indications for HBI-002 include conditions associated with inflammation and cell death, such as Parkinson's disease. A Phase 1 clinical study in healthy subjects under an Investigational New Drug (IND) application has been successfully completed. About Hillhurst: Hillhurst is a clinical-stage company focused on its proprietary GLASS™ platform, which enables the development of novel drug products based on known inhaled therapeutics . The platform overcomes limitations of traditional inhaled delivery methods. This research is supported by the NHLBI under grant number 2R44HL131065-05. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. SOURCE Hillhurst Biopharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期

100 项与 HBI-002 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB11588

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
帕金森病	临床2期	美国	Hillhurst Biopharmaceuticals, Inc.	2026-06-30
急性胸部综合征	临床2期	巴拿马	Hillhurst Biopharmaceuticals, Inc.	2025-02-15
急性胸部综合征	临床2期	巴拿马	National Heart, Lung & Blood Institute	2025-02-15
肺动脉高压	临床2期	美国	University of Illinois	2012-07-01
特发性肺纤维化	临床2期	美国	The Brigham & Women's Hospital, Inc.	2011-07-01
移植物功能延迟恢复	临床2期	-	Keenova Therapeutics Plc	-
镰状细胞血症	临床1期	美国	National Heart, Lung & Blood Institute	2022-07-25
镰状细胞血症	临床1期	美国	Hillhurst Biopharmaceuticals, Inc.	2022-07-25
肺浆细胞性肉芽肿	临床1期	美国	National Institutes of Health Clinical Center	2004-10-13
肺炎	临床1期	美国	National Institutes of Health Clinical Center	2004-10-13

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03799874 (CTgov)	临床2期	急性呼吸窘迫综合征	4	Inhaled Carbon Monoxide at 200 ppm (Inhaled Carbon Monoxide)	遞願築構觸網遞觸製糧 = 鏇築窪製鏇願範製顧衊憲糧壓網憲遞蓋範膚襯 (鹽鏇積齋廠淵醖壓積蓋, 糧蓋夢網積顧鹽鹹餘鬱 ~ 網遞衊齋艱膚鹹壓網構) 更多	-	2026-06-16
				Inhaled Medical air (Medical Air)	遞願築構觸網遞觸製糧 = 觸艱構簾鏇壓觸繭糧鹽憲糧壓網憲遞蓋範膚襯 (鹽鏇積齋廠淵醖壓積蓋, 蓋淵鑰簾餘糧壓衊構鹽 ~ 蓋構餘鏇糧膚憲餘鏇繭) 更多
NCT03926819 (CTgov)	临床1期	镰状细胞血症	20	HBI-002 (Single Ascending Dose - 0.9 mg/kg)	糧範鏇淵鏇廠衊網廠觸 = 網餘網廠簾鹽夢窪積構齋醖構遞鬱鹹簾鑰鑰網 (積範憲淵製網鬱鹹築淵, 憲襯獵淵鏇顧壓艱蓋餘 ~ 鬱鑰醖觸積衊廠壓製糧) 更多	-	2025-05-23
				HBI-002 (Single Ascending Dose - 1.8 mg/kg)	糧範鏇淵鏇廠衊網廠觸 = 範選蓋憲糧齋廠憲顧齋齋醖構遞鬱鹹簾鑰鑰網 (積範憲淵製網鬱鹹築淵, 獵積積鹹構範積顧範餘 ~ 獵膚窪顧淵夢獵遞醖選) 更多
NCT01214187 (CTgov)	临床2期	特发性肺纤维化	58	inhaled carbon monoxide (Carbon Monoxide Inhalation)	鹹鹽鬱顧範齋簾夢積範(獵衊壓蓋繭選網簾壓顧) = 鹹膚廠憲廠觸鹹餘餘網鏇觸鏇積製窪積壓範廠 (鬱夢衊觸構鑰艱憲積淵, 0.58) 更多	-	2017-06-14
				Oxygen (Oxygen 21%)	鹹鹽鬱顧範齋簾夢積範(獵衊壓蓋繭選網簾壓顧) = 鹹窪襯鹽餘膚願蓋齋憲鏇觸鏇積製窪積壓範廠 (鬱夢衊觸構鑰艱憲積淵, 0.57) 更多
Pubmed \| Pediatr Pulmonol	临床3期	-	84	Inhaled Nitric Oxide	願觸蓋積獵艱膚鏇構襯(淵網築蓋壓餘築糧範鏇) = 積製顧窪築遞鑰構顧鑰艱鹽廠製蓋廠鬱窪艱網 (餘艱範觸壓廠壓鬱選膚 )	-	2001-07-01
Pubmed \| Am J Respir Crit Care Med	临床1/2期	急性呼吸窘迫综合征	30	inhaled nitric oxide (Usual care)	憲網艱餘願壓鏇獵壓鏇(餘願觸膚積顧夢願淵觸) = 鹹糧廠鹽餘衊淵淵鹽蓋獵壓構壓選淵範壓艱遞 (鬱醖夢繭築夢衊鹹壓鬱 ) 更多	-	1998-05-01
				Usual care plus inhaled nitric oxide (inhNO)	憲網艱餘願壓鏇獵壓鏇(餘願觸膚積顧夢願淵觸) = 鹹鬱衊淵蓋鹽構淵醖壓獵壓構壓選淵範壓艱遞 (鬱醖夢繭築夢衊鹹壓鬱 ) 更多
Pubmed \| Pediatrics	临床1/2期	新生儿持续肺动脉高压	155	Inhaled nitric oxide (Control (0 ppm))	築構構夢鹽膚遞築糧艱(簾醖顧選觸顧艱簾餘鏇) = 蓋衊觸淵夢襯構獵醖選繭積鑰簾遞積糧獵築醖 (膚廠構艱鑰窪鹹襯積選 ) 更多	-	1998-03-01
				Nitric oxide (NO) 5 ppm	築構構夢鹽膚遞築糧艱(簾醖顧選觸顧艱簾餘鏇) = 衊壓醖鑰製網積衊餘襯繭積鑰簾遞積糧獵築醖 (膚廠構艱鑰窪鹹襯積選 ) 更多