MIRA Pharmaceuticals Reports New Topical Ketamir-2 shows comparable effects to Injected Morphine in Preclinical Pain Study
MIRA Pharmaceuticals (NASDAQ:MIRA) announced promising preclinical data for its topical Ketamir-2 cream, demonstrating comparable pain relief efficacy to injected morphine in a validated animal model. The study showed the cream effectively reduced both acute and inflammatory pain behaviors, with rapid onset and durable effects.
The research utilized the formalin model to evaluate pain responses, with Ketamir-2 showing strong performance in both initial acute phase and prolonged inflammatory phase. The company is developing Ketamir-2 in both oral and topical forms, targeting the $11.5 billion U.S. topical pain market. MIRA plans to begin a Phase 2a neuropathic pain trial for the oral formulation by year-end, following their current Phase 1 trial in healthy volunteers.
MIRA Pharmaceuticals (NASDAQ:MIRA) ha annunciato dati preclinici promettenti per la sua crema topica Ketamir-2, dimostrando un'efficacia nel sollievo dal dolore comparabile a quella della morfina iniettabile in un modello animale validato. Lo studio ha evidenziato che la crema riduce efficacemente sia il dolore acuto che quello infiammatorio, con un rapido inizio d'azione e effetti duraturi.
La ricerca ha utilizzato il modello della formalina per valutare le risposte al dolore, con Ketamir-2 che ha mostrato ottime prestazioni sia nella fase acuta iniziale che in quella infiammatoria prolungata. L'azienda sta sviluppando Ketamir-2 sia in forma orale che topica, mirando al mercato statunitense del dolore topico da 11,5 miliardi di dollari. MIRA prevede di avviare entro fine anno uno studio di Fase 2a sul dolore neuropatico per la formulazione orale, a seguito dell'attuale studio di Fase 1 su volontari sani.
MIRA Pharmaceuticals (NASDAQ:MIRA) anunció datos preclínicos prometedores para su crema tópica Ketamir-2, demostrando una eficacia para aliviar el dolor comparable a la morfina inyectada en un modelo animal validado. El estudio mostró que la crema reduce eficazmente tanto el dolor agudo como el inflamatorio, con un inicio rápido y efectos duraderos.
La investigación utilizó el modelo de formalina para evaluar las respuestas al dolor, con Ketamir-2 mostrando un buen desempeño tanto en la fase aguda inicial como en la fase inflamatoria prolongada. La compañía está desarrollando Ketamir-2 en formas oral y tópica, apuntando al mercado estadounidense de dolor tópico de 11.5 mil millones de dólares. MIRA planea iniciar un ensayo de Fase 2a para dolor neuropático de la formulación oral para fin de año, tras su actual ensayo de Fase 1 en voluntarios sanos.
MIRA Pharmaceuticals (NASDAQ:MIRA)는 국소용 Ketamir-2 크림에 대한 유망한 전임상 데이터를 발표했으며, 검증된 동물 모델에서 주사형 모르핀과 유사한 통증 완화 효과를 입증했습니다. 연구 결과, 이 크림은 급성 및 염증성 통증 행동을 효과적으로 감소시키며 빠른 발현과 지속적인 효과를 나타냈습니다.
연구는 포름알데히드 모델을 사용하여 통증 반응을 평가했으며, Ketamir-2는 초기 급성기와 장기 염증기 모두에서 뛰어난 성능을 보였습니다. 회사는 Ketamir-2를 경구 및 국소용 형태로 개발 중이며, 미국 국소 통증 시장 115억 달러 규모를 목표로 하고 있습니다. MIRA는 현재 건강한 자원자를 대상으로 한 1상 시험에 이어 연말까지 경구 제형의 2a상 신경병증성 통증 시험을 시작할 계획입니다.
MIRA Pharmaceuticals (NASDAQ:MIRA) a annoncé des données précliniques prometteuses pour sa crème topique Ketamir-2, démontrant une efficacité comparable à celle de la morphine injectée dans un modèle animal validé. L'étude a montré que la crème réduisait efficacement les douleurs aiguës et inflammatoires, avec un début d'action rapide et des effets durables.
La recherche a utilisé le modèle de la formol pour évaluer les réponses à la douleur, Ketamir-2 montrant de bonnes performances tant dans la phase aiguë initiale que dans la phase inflammatoire prolongée. La société développe Ketamir-2 sous forme orale et topique, visant le marché américain de la douleur topique de 11,5 milliards de dollars. MIRA prévoit de lancer d'ici la fin de l'année un essai de phase 2a sur la douleur neuropathique pour la formulation orale, après leur essai de phase 1 actuel chez des volontaires sains.
MIRA Pharmaceuticals (NASDAQ:MIRA) hat vielversprechende präklinische Daten für seine topische Ketamir-2-Creme veröffentlicht, die eine vergleichbare Schmerzlinderung wie injizierte Morphin in einem validierten Tiermodell zeigen. Die Studie zeigte, dass die Creme sowohl akute als auch entzündliche Schmerzreaktionen wirksam reduzierte, mit schnellem Wirkungseintritt und anhaltender Wirkung.
Die Forschung nutzte das Formalin-Modell zur Bewertung der Schmerzreaktionen, wobei Ketamir-2 sowohl in der akuten Anfangsphase als auch in der verlängerten Entzündungsphase starke Leistungen zeigte. Das Unternehmen entwickelt Ketamir-2 in oraler und topischer Form und zielt auf den 11,5 Milliarden US-Dollar schweren US-Markt für topische Schmerzmittel ab. MIRA plant, bis Jahresende eine Phase-2a-Studie bei neuropathischen Schmerzen für die orale Formulierung zu starten, nach der aktuellen Phase-1-Studie an gesunden Freiwilligen.
- Topical Ketamir-2 demonstrated comparable efficacy to injected morphine in pain relief
- Drug showed effectiveness in both acute and inflammatory pain phases
- Minimal systemic exposure due to localized delivery mechanism
- Targets $11.5 billion U.S. topical pain market opportunity
- Dual-path development strategy (oral and topical) expands market potential
- Still in early preclinical stage for topical formulation
- Clinical trials in humans not yet initiated for topical version
- Will face significant competition in crowded pain management market
Insights
MIRA's topical Ketamir-2 shows promising preclinical efficacy comparable to morphine, expanding their pain treatment platform beyond oral formulations.
MIRA Pharmaceuticals has released compelling preclinical data for their topical Ketamir-2 cream that significantly strengthens their pain treatment platform. The study demonstrated that topical Ketamir-2 provided comparable pain relief to injected morphine in a validated animal model measuring both acute and inflammatory pain phases—a rare achievement for topical treatments.
The formalin model used is particularly valuable as it evaluates two distinct pain mechanisms: direct nerve activation (acute phase) and central sensitization (inflammatory phase). Ketamir-2's effectiveness across both pain phases suggests a versatile mechanism of action that could address multiple pain pathways through local application, potentially without systemic side effects.
This data strategically expands MIRA's development approach to a dual-route platform. With their oral formulation already advancing to Phase 2a clinical trials for neuropathic pain by year-end, the addition of a viable topical option substantially broadens their addressable market and clinical applications to include localized conditions like diabetic neuropathy, chemotherapy-induced neuropathy, and osteoarthritis.
The company is targeting the $11.5 billion U.S. topical pain market, which has significant demand for non-opioid alternatives. This dual-formulation strategy (oral and topical) is relatively uncommon and gives MIRA multiple shots on goal across different pain indications and administration preferences, potentially creating distinct value streams from the same compound.
While these are preclinical results requiring further validation in human trials, they represent a meaningful expansion of MIRA's development strategy beyond their current Phase 1 oral formulation program.
Topical Ketamir-2 significantly reduced both acute and inflammatory pain behaviors in animals, demonstrating rapid onset, durable effect, and comparable efficacy to injected morphine across both pain phases
MIAMI, FLORIDA / ACCESS Newswire / July 30, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced new preclinical data showing that its topical Ketamir-2 cream delivered similar and consistent pain relief compared with injected morphine in a validated animal model of acute and inflammatory pain.
In the study, Ketamir-2 cream was applied topically to the affected area 30 minutes before pain was induced using the formalin model, a widely accepted preclinical method for evaluating both acute and inflammatory pain. In this model, a small amount of formalin (a dilute formaldehyde solution) is injected into the paw, producing two well-characterized phases of pain: an initial acute phase driven by direct nerve activation, followed by a prolonged inflammatory phase associated with central sensitization (a mechanism shared with neuropathic pain). Researchers monitored spontaneous pain-related behaviors-specifically paw licking and paw lifting-using AI-assisted video analysis of 5-minute slots over a 60-minute period.
Topical Ketamir-2 was effective as Injected morphine in both phases, nearly eliminating pain behaviors during the acute phase and maintaining a strong, durable effect throughout the inflammatory phase. These results indicate Ketamir-2's potential to modulate both peripheral and central pain pathways with topical, localized delivery.
"These findings confirm Ketamir-2's potential as a next-generation, non-opioid topical treatment for localized pain," said Erez Aminov, Chairman and CEO of MIRA. "With our oral IND already cleared and a Phase 2a neuropathic pain trial expected to begin by year-end, this topical data meaningfully expands our clinical and commercial strategy. We're advancing a dual-route platform that can target both systemic and localized pain conditions-offering optionality for patients and value for shareholders."
Dual-Phase Pain Relief Without Systemic Burden
Unlike systemic analgesics, which circulate throughout the body and may cause unwanted side effects, Ketamir-2's topical formulation is designed to provide direct, localized pain relief with minimal systemic exposure. Its performance across both acute and inflammatory pain phases supports a broad therapeutic profile-potentially applicable to conditions such as diabetic neuropathy, chemotherapy-induced peripheral neuropathy (CIPN), postherpetic neuralgia, and osteoarthritis.
"What's remarkable is Ketamir-2's ability to nearly abolish acute pain behavior while also suppressing inflammation-driven responses," said Dr. Itzchak Angel, CSA at MIRA. "This dual-phase efficacy is rarely seen with topicals and strongly supports our rationale to continue advancing preclinical studies aimed at treating complex localized pain conditions."
Addressing an
The U.S. topical pain relief market is projected to exceed
Ketamir-2's topical formulation is designed to meet this need by offering:
Fast onset of action
Efficacy in both neurogenic and inflammatory pain
Minimal systemic absorption
Non-opioid, non-habit forming mechanism of action
Unlike many pain programs that pursue either systemic or localized delivery, MIRA is developing Ketamir-2 in both oral and topical forms. This dual-path approach may enable clinical evaluation across a broader spectrum of pain conditions-ranging from widespread neuropathic syndromes to localized inflammatory pain. If successful, this strategy could support differentiated product profiles and expand potential treatment opportunities.
A Scalable Non-Opioid Pain Platform
MIRA is currently conducting a Phase 1 clinical trial of oral Ketamir-2 in healthy volunteers. Following FDA clearance of its Investigational New Drug (IND) application, a Phase 2a clinical trial in neuropathic pain is expected to begin later this year in the USA.
The Company is also continuing preclinical development of the topical formulation to further characterize its pharmacological effects and support potential clinical advancement. Together, these efforts reflect a platform strategy designed to address high-burden pain conditions through both systemic and localized approaches.
"As we continue to execute on our clinical and regulatory milestones, we remain focused on unlocking the full value of the Ketamir-2 platform-either through internal advancement or strategic partnership," added Aminov.
About MIRA Pharmaceuticals, Inc.
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates designed to address significant unmet medical needs in areas such as neuropathic pain, inflammatory pain, obesity, addiction, anxiety, and cognitive decline.
Cautionary Note Regarding Forward-Looking Statements
This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on MIRA's website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Contact:
Helga Moya
info@mirapharma.com
(786) 432-9792
SOURCE: MIRA Pharmaceuticals
View the original press release on ACCESS Newswire
FAQ
What were the key findings of MIRA's Ketamir-2 preclinical pain study?
How does MIRA's Ketamir-2 topical treatment work differently from traditional pain medications?
What is the market potential for MIRA's Ketamir-2?
What are the next steps in MIRA's Ketamir-2 development pipeline?
How many adults are affected by chronic pain in the U.S.?
