Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Monad 1 · 1 trial · 1 indication
Change in hemorrhoidal symptoms (pain, burning, itching, and swelling) as measured by the patient using a numeric rating scale.
| Arm | Type | Description |
|---|---|---|
| Monad 1 cream | ACTIVE_COMPARATOR | Topical cream applied to the peri-anal area twice daily for seven days. |
| Monad 2 cream | ACTIVE_COMPARATOR | Topical cream applied to the peri-anal area twice daily for seven days. |
| Monad 3 cream | ACTIVE_COMPARATOR | Topical cream applied to the peri-anal area twice daily for seven days. |
| Combination-CITI-002 (low dose) cream | EXPERIMENTAL | Topical cream applied to the peri-anal area twice daily for seven days. |
| Combination-CITI-002 (high dose) cream | EXPERIMENTAL | Topical cream applied to the peri-anal area twice daily for seven days. |
| Name | Type | Description |
|---|---|---|
| Monad 1 | DRUG | Single therapy cream containing Lidocaine. Lidocaine is a topical anesthetic. |
| Monad 2 | DRUG | Single therapy cream containing Halobetasol Propionate (low-strength). HPB is a topical corticosteroid. |
| Monad 3 | DRUG | Single therapy cream containing Halobetasol Propionate (high strength). |
| Combination - CITI-002 (low dose) | DRUG | Combination cream containing Lidocaine and HBP (low) |
| Combination - CITI-002 (high dose) | DRUG | Combination cream containing Lidocaine and HBP (high) |
Inclusion Criteria: * Male or non-pregnant female 18 years of age or older. * Signs written informed consent for the study. * Females must be post-menopausal , surgically sterile , or use an effective method of birth control, or women of childbearing potential (WOCBP) must have a negative Urine Pre...
Monad 1 is an investigational small molecule being developed for the treatment of hemorrhoids. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in adult patients with moderate grade hemorrhoids.
Monad 1 is being developed by Citius Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CTXR. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for hemorrhoids.
Monad 1 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The Phase 2 trial has been completed, and the drug remains under clinical investigation for the treatment of hemorrhoids.
Monad 1 has one completed Phase 2 clinical trial, identified as NCT05348200, titled "Safety and Efficacy of CITI-002 in Adult Patients With Moderate Grade Hemorrhoids." The trial enrolled 304 participants in the United States and was randomized, double-blind, and active-controlled.
Yes, Monad 1 is also known as CITI-002. The Phase 2 clinical trial NCT05348200 refers to the drug as CITI-002, and it is being studied for the treatment of moderate grade hemorrhoids in adult patients.