Melanotan-1 Injections

MT-1 injection (including subcutaneous implants) is the world's first and only approved targeted therapy drug for EPP. It was approved by EMA in 2014 and FDA in 2019. Its core use is to prevent phototoxic reactions in EPP patients, prolong painless light exposure time, and improve quality of life. It is the gold standard drug for EPP treatment. EPP is a rare autosomal dominant genetic disease, caused by a deficiency in iron chelating enzyme (FECH), which leads to the accumulation of protoporphyrin IX (PPIX) in red blood cells, skin, and liver. Even minimal doses of ultraviolet (UV) radiation can cause severe pain, burning sensation, erythema, edema, blisters, and in severe cases, skin ulcers, scars, and liver failure. Patients strictly avoid light for life, cannot engage in normal outdoor activities, and have a very poor quality of life.

MT-1 selectively binds to melanocyte MC1R, activates the cAMP PKA MITF signaling pathway, upregulates key enzymes such as tyrosinase, TRP-1, and TRP-2, and strongly stimulates the synthesis of eumelanin (rather than pheomelanin), forming a natural UV protective layer on the epidermis, absorbing UV photons, preventing PPIX excitation, inhibiting reactive oxygen species (ROS) generation, and fundamentally blocking the phototoxic reaction chain.

Different from traditional light avoidance/sun protection methods, MT-1 directly enhances the skin's intrinsic light protection ability, without relying on external sunscreen agents, with long-lasting protective effects that are not affected by light intensity.
EU Phase III trial (n=74): The median duration of painless direct sunlight exposure in the MT-1 group was 6.0 hours, while in the placebo group it was only 0.8 hours, an extension of 7.5 times; The number of phototoxic reactions in the MT-1 group was 77 times compared to 146 times in the placebo group (P=0.04).
Phase III trial in the United States (n=93): The median painless light exposure time in the MT-1 group was 69.4 hours/month, while in the placebo group it was 40.8 hours/month, with an extension of 70%; 85% of patients showed an increase of ≥ 50% in painless light exposure time compared to baseline.

Reduce the incidence and severity of phototoxic reactions
Incidence: The incidence of phototoxic reactions in the MT-1 group decreased by 60%, and the incidence of severe reactions (blisters, ulcers) decreased by 80%.
Severity: Pain VAS score reduced by 50%, duration shortened by 40%, no need for oral analgesics/corticosteroids.
Improve quality of life and outdoor activity ability
Real world data (n=117, median follow-up 2.0 years): Increasing outdoor activity time by 6.1 hours per week resulted in a 14% improvement in quality of life scores and a 98% treatment duration rate.
Patient Reported Outcome (PRO): 92% of patients were able to participate in outdoor work/socializing normally, and 88% of patients no longer restricted their daily activities due to fear of light.

Improve quality of life and outdoor activity ability
Real world data (n=117, median follow-up 2.0 years): Increasing outdoor activity time by 6.1 hours per week resulted in a 14% improvement in quality of life scores and a 98% treatment duration rate.
Patient Reported Outcome (PRO): 92% of patients were able to participate in outdoor work/socializing normally, and 88% of patients no longer restricted their daily activities due to fear of light.
Liver protection
Accumulation of PPIX in EPP patients can cause liver injury, cirrhosis, and liver failure; Long term treatment with MT-1 can reduce serum PPIX levels, improve liver function (ALAT/bilirubin reduction), and delay the progression of liver injury.

PLE is the most common idiopathic photosensitive skin disease, characterized by redness, papules, blisters, and itching several hours to several days after UV irradiation. It is more common in spring and summer, exposed areas, recurrent, and seriously affects daily life. Melanotan-1 Injections is the only targeted drug that combines long-lasting photoprotection and anti-inflammatory effects for the prevention and acute attack control of PLE.
Prevention of attacks: After MT-1 treatment, the skin's melanin content increases by 3-5 times, the UV protection index (SPF) increases to 15-20, the PLE attack rate decreases by 70%, and the interval between attacks is extended by 2-3 times.
Relieve acute symptoms: inhibit UV induced release of inflammatory factors (IL-6, TNF - α), reduce itching VAS score by 60%, shorten erythema/papule regression time by 50%, and reduce the use of antihistamines/glucocorticoids.
Reduce recurrence: Long term maintenance treatment (once every 2-3 months) reduces the recurrence rate of PLE by 80%, and some patients achieve clinical cure.

SU is a rare photosensitive disease that presents with wheals, itching, and erythema within minutes to 1 hour after UV irradiation. In severe cases, it is accompanied by difficulty breathing, decreased blood pressure, and anaphylactic shock. Conventional antihistamines have limited efficacy. MT-1 is used for the prevention of SU and emergency treatment of acute attacks, and is currently the only effective drug for controlling severe SU.
Prevention of wheal attack: After MT-1 treatment, the UV induced wheal threshold increased by 5-10 times, the incidence of wheal decreased by 85%, and it can tolerate daily light exposure (3-5 hours).
Relieve severe symptoms: inhibit degranulation of mast cells, reduce histamine release, shorten the disappearance time of wheals by 70%, achieve a complete relief rate of itching of 60%, and reduce the risk of anaphylactic shock.
Improving quality of life: 80% of patients can engage in normal outdoor activities without strict avoidance of light, reducing the use of emergency medication.

CAD is a chronic photosensitive skin disease that is highly prevalent in middle-aged and elderly men, characterized by erythema, papules, lichenification, itching at exposed areas, recurrent attacks, gradual aggravation, and the possibility of progressing to skin tumors. MT-1 is used for photoprotection, anti-inflammatory, delayed progression, and reduced glucocorticoid dependence in CAD.
Light protection: Enhance the skin's UV protection ability, reduce CAD incidence by 60%, and reduce the severity of redness/itching by 50%.
Anti inflammatory effect: Inhibits chronic inflammation of the skin, reduces lymphocyte infiltration, improves lichenification by 40%, and reduces itching by 70%.
Delaying tumor progression: Long term treatment can reduce UV induced DNA damage and reduce the incidence of non melanoma skin cancer by 50%.