MedPath

Minocycline

Generic Name
Minocycline
Brand Names
Amzeeq, Arestin, Dynacin, Minocin, Minolira, Solodyn, Ximino, Zilxi
Drug Type
Small Molecule
Chemical Formula
C23H27N3O7
CAS Number
10118-90-8
Unique Ingredient Identifier
FYY3R43WGO
Background

Minocycline was first described in the literacture in 1966. It is a second generation tetracycline antibiotic that is active against gram-negative and gram-positive bacteria. Like other semisynthetic tetracyclines, minocycline has modifications to carbons 7-9 on the D ring to generate higher efficacy than previous tetracyclines.

Minocycline was granted FDA approval on 30 June 1971.

Indication

Oral and topical minocycline are indicated to treat inflammatory lesions of acne vulgaris. Subgingival microspheres are indicated as an adjunct treatment in the reduction of pocket depth in adults with periodontitis. Oral and intravenous formulations are indicated to treat infections of susceptible microorganisms. These include rickettsiae, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydophila psittaci, Chlamydia trachomatis, Ureaplasma urealyticum, Borrelia recurrentis, Haemophilus ducreyi, Yersinia pestis, Francisella tularensis, Vibrio cholerae, Campylobacter fetus, Brucella species, Bartonella bacilliformis, Klebsiella granulomatis, Escherichia coli, Enterobacter aerogenes, Shigella species, Acinetobacter species, Haemophilus influenzae, and Kelbsiella species.

Associated Conditions
Bartonellosis, Brucellosis, Campylobacter fetus, Chancroid, Cholera (Disorder), Conjunctivitis, Inclusion, Granuloma Inguinale, Lymphogranuloma Venereum, Nongonococcal urethritis, Periodontitis, Plague, Psittacosis, Q Fever, Relapsing Fever, Respiratory Tract Infections (RTI), Rickettsia Infections, Rickettsialpox, Rocky Mountain Spotted Fever, Trachoma, Tularemia, Typhus infections, Inflammatory lesions

New Guidelines and Therapies Reshape Acne Treatment Approach in 2025

• The American Academy of Dermatology's 2024 updated acne guidelines recommend limiting systemic antibiotic use and emphasize treating all four pillars of acne pathogenesis simultaneously. • Several new FDA-approved acne medications since 2019 have expanded treatment options, including Winlevi (clascoterone), the only topical therapy effective for excessive sebum production. • Dermatology experts now recommend simpler treatment regimens with fewer products that address multiple pathogenic factors, with a growing focus on early intervention to prevent scarring.

Fortress Biotech Reports Strong 2024 Results with Two FDA Approvals and Strategic Acquisition Deal

• Fortress Biotech secured FDA approvals for two key products in Q4 2024: Emrosi for inflammatory lesions of rosacea and UNLOXCYT for advanced cutaneous squamous cell carcinoma, with commercial launch of Emrosi already underway. • Subsidiary Checkpoint Therapeutics is being acquired by Sun Pharma in a deal valued at $4.10 per share plus potential CVR of $0.70, expected to generate approximately $28 million for Fortress plus a 2.5% royalty on UNLOXCYT sales. • FDA accepted New Drug Application for CUTX-101 for priority review with PDUFA date of September 30, 2025, potentially qualifying for a valuable Priority Review Voucher upon approval.

Rosacea Therapeutics Pipeline Shows Promise with Emerging Therapies

• Over 25 companies are developing novel rosacea treatments, indicating a robust pipeline. • Key emerging therapies like Epsolay, M 1220, and BMX-010 are expected to significantly impact the rosacea market. • Sol-Gel Technologies and Maruho Co., Ltd. are among the leading companies in developing advanced-stage rosacea drugs. • Recent regulatory approvals, such as Zydus Lifesciences' metronidazole topical cream, offer new treatment options.

Eirion Therapeutics' ET-02 Shows Promise in Phase 1 Trial for Androgenic Alopecia

• Eirion Therapeutics announced positive results from its first-in-man clinical trial of topical ET-02 for androgenic alopecia. • The Phase 1 trial demonstrated that ET-02 was safe and well-tolerated among participants. • Early results indicated that improvements were observed as early as 5 weeks into the treatment. • The 5% dosage of ET-02 showed a significant increase in non-vellus hair count, marking a potential breakthrough in hair loss treatment.

FDA Approves Emrosi (Minocycline Hydrochloride) for Rosacea Treatment in Adults

• The FDA has approved Emrosi (minocycline hydrochloride) as a 40mg extended-release capsule for treating inflammatory lesions of rosacea in adults. • Emrosi demonstrated statistically significant superiority over Oracea and placebo in Phase 3 trials, showing success in Investigator’s Global Assessment and lesion reduction. • Journey Medical anticipates launching Emrosi in early 2025, positioning it as a potential best-in-class oral medication for rosacea with a favorable safety profile. • Emrosi's extended-release formulation delivers minocycline steadily, mitigating drug level fluctuations and improving tolerability for patients with rosacea.

FDA Grants Priority Review to CUTX-101 for Menkes Disease, Offering Hope for Rare Pediatric Condition

• The FDA has accepted Sentynl Therapeutics' NDA for CUTX-101, granting priority review for the treatment of Menkes disease, a rare genetic disorder. • Clinical trials of CUTX-101 demonstrated an almost 80% reduction in mortality risk compared to untreated patients, significantly improving overall survival. • CUTX-101 has been granted multiple designations, including Breakthrough Therapy and Orphan Drug, highlighting its potential to address a critical unmet need. • Cyprium Therapeutics is eligible to receive up to $129 million in milestone payments and royalties, retaining ownership of a potential Priority Review Voucher.

Citius Oncology Explores Strategic Options Post-Lymphir Approval for T-Cell Lymphoma

• Citius Oncology is considering strategic alternatives, including partnerships and acquisitions, after FDA approval of Lymphir for relapsed or refractory cutaneous T-cell lymphoma (CTCL). • Lymphir, targeting the interleukin-2 (IL-2) receptor, is the first drug specifically for CTCL and aims to address an underserved market estimated at over $400 million. • Citius plans to launch Lymphir in the first half of the year, focusing on manufacturing, marketing, reimbursement, and sales, while also exploring expanded indications and international partnerships. • Citius Pharmaceuticals is also advancing Mino-Lok, an antibiotic lock solution for catheter-related bloodstream infections, following positive Phase 3 trial results.

Citius Pharma Reports Fiscal Year 2024 Results, Highlights LYMPHIR Approval and Mino-Lok Progress

• Citius Pharmaceuticals (Citius Pharma) achieved FDA approval for LYMPHIR for relapsed or refractory cutaneous T-cell lymphoma (CTCL). • The company's Phase 3 trial of Mino-Lok met primary and secondary endpoints, showing statistically significant improvement in catheter failure time. • Citius Pharma is preparing for the commercial launch of LYMPHIR in the first half of 2025 and plans to engage with the FDA on Mino-Lok and Halo-Lido. • The company reported a net loss of $39.4 million for fiscal year 2024, with R&D expenses decreasing and G&A expenses increasing.

FDA Approves Journey Medical's Emrosi™ for Rosacea Treatment

• The FDA has approved Emrosi™ (minocycline hydrochloride extended-release capsules, 40 mg) for treating inflammatory lesions of rosacea in adults. • Journey Medical anticipates launching Emrosi™ in late Q1 or early Q2 of 2025, expanding their dermatology-focused product portfolio. • Clinical data presented at the 44th Fall Clinical Dermatology Conference highlighted Emrosi's higher dermal concentration compared to doxycycline. • The approval marks a significant advancement in rosacea treatment, addressing a prevalent dermatological condition.

FDA Approves Checkpoint Therapeutics' Unloxcyt for Advanced Cutaneous Squamous Cell Carcinoma

• The FDA has approved Unloxcyt (cosibelimab-ipdl) for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in adults who cannot undergo surgery or radiation. • Approval was based on Study CK-301-101, showing a 47% objective response rate in metastatic cSCC and 48% in locally advanced cSCC patients. • Unloxcyt is administered intravenously every three weeks and is the first PD-L1 blocking antibody approved for this specific indication. • Common adverse reactions include fatigue, musculoskeletal pain, rash, diarrhea and hypothyroidism, with serious immune-mediated reactions possible.

Citius Pharma Gains Clarity from FDA on Mino-Lok's Path to Approval for CRBSI

• Citius Pharmaceuticals completed a Type C meeting with the FDA to discuss the Phase 3 Mino-Lok program for catheter-related bloodstream infections (CRBSI). • The FDA provided clear and actionable guidance, supporting a potential New Drug Application (NDA) submission for Mino-Lok. • Mino-Lok, if approved, would be the first FDA-approved treatment to salvage central venous catheters, potentially reducing healthcare costs and improving patient outcomes. • Citius Pharma is committed to advancing the Mino-Lok program and will provide updates on regulatory and clinical developments.

Citius Pharma Advances Mino-Lok Approval Pathway Following FDA Meeting

• Citius Pharmaceuticals recently met with the FDA to discuss the NDA pathway for Mino-Lok, an antibiotic lock solution for infected central venous catheters. • The FDA provided constructive feedback on regulatory considerations and clinical data needed to support the NDA submission for Mino-Lok. • Mino-Lok aims to offer an alternative to catheter removal, potentially improving the management of catheter-related bloodstream infections and reducing healthcare costs. • Citius Pharma remains dedicated to advancing the Mino-Lok program and will continue to update on regulatory and clinical developments.

Citius Pharma Gains FDA Guidance on Mino-Lok Phase 3 Program for CLABSI

• Citius Pharmaceuticals received constructive feedback from the FDA regarding its Phase 3 Mino-Lok program, aimed at salvaging central venous catheters in patients with CLABSI. • The FDA's guidance supports a potential New Drug Application (NDA) submission for Mino-Lok, addressing critical aspects like in-vitro data, clinical efficacy, safety, and regulatory considerations. • Mino-Lok, combining minocycline, ethanol, and edetate disodium, offers a novel approach to treating catheter-related bloodstream infections, potentially reducing healthcare costs and improving patient outcomes. • Citius Pharma is committed to advancing the Mino-Lok program and will provide updates on regulatory and clinical developments.

Citius Pharma Gains Clarity on Mino-Lok's Regulatory Path After FDA Meeting

• Citius Pharmaceuticals reports a productive Type C meeting with the FDA regarding its Mino-Lok program for catheter-related bloodstream infections (CRBSI). • The FDA provided clear and actionable guidance, supporting a potential New Drug Application (NDA) submission for Mino-Lok. • Mino-Lok demonstrated compelling clinical outcomes in a Phase 3 trial, offering a potential alternative to catheter removal and reducing healthcare costs. • Citius Pharma is committed to advancing the Mino-Lok program and will provide updates on regulatory and clinical developments.

Lymphir and Keytruda Combination Shows Promise in Advanced Lymphoma

• A clinical trial combining Lymphir with Keytruda demonstrated a 33% clinical benefit rate and a 27% overall response rate in lymphoma patients with extensive prior treatment history. • Patients who benefited from the Lymphir-Keytruda combination experienced a median progression-free survival of 57 weeks, indicating a substantial improvement in outcomes. • The combination therapy exhibited a favorable safety profile, with most adverse events attributed to the underlying disease rather than the treatment itself. • Analysts from Maxim Group and H.C. Wainwright have reiterated a Buy rating on Citius Pharmaceuticals (CTXR) with a $4.00 price target, citing the promising clinical data.

FDA Approves Journey Medical's Emrosi (Minocycline HCl) for Rosacea

• The FDA has approved Journey Medical's Emrosi (minocycline hydrochloride extended-release capsules, 40 mg) for treating inflammatory lesions of rosacea in adults. • Emrosi's approval is based on positive Phase 3 trial data (MVOR-1 and MVOR-2) demonstrating efficacy and tolerability compared to placebo and Oracea (doxycycline 40mg). • Journey Medical anticipates Emrosi will be available in the US market in late Q1 or early Q2 2024, offering a new oral standard of care. • Rosacea affects over 16 million Americans, and Emrosi aims to address the condition's impact on self-esteem and social interactions.

FDA Approves Journey Medical's Emrosi for Rosacea Treatment

• The FDA has approved Journey Medical's Emrosi (minocycline hydrochloride extended-release capsules) for treating rosacea, a chronic inflammatory skin condition. • Phase III clinical trials demonstrated Emrosi's statistically significant superiority over placebo and the current standard of care, Oracea, in reducing rosacea symptoms. • Journey Medical anticipates Emrosi will be available to U.S. patients in the first half of 2025, aiming to establish it as a new standard of care. • Emrosi's approval marks a potential shift in the rosacea treatment market, where Journey Medical seeks to become a leading player.

FDA Approves Emrosi (DFD-29) for Rosacea-Related Inflammatory Lesions in Adults

• The FDA has approved Emrosi (minocycline hydrochloride extended-release capsules, 40 mg) for treating inflammatory lesions caused by rosacea in adults. • Approval was based on positive results from two Phase 3 clinical trials (MVOR-1 and MVOR-2) that demonstrated statistically significant superiority over placebo and doxycycline. • DFD-29 showed greater Investigator's Global Assessment (IGA) treatment success and reduction in total inflammatory lesion count compared to both placebo and doxycycline. • A pharmacokinetic study showed DFD-29 provides higher dermal concentrations of minocycline compared to doxycycline from Day 1, suggesting a clinically meaningful impact.

FDA Approves Journey Medical's Emrosi (Minocycline) for Rosacea

• The FDA has approved Journey Medical's Emrosi (minocycline hydrochloride extended-release capsules, 40 mg) for treating rosacea in adults. • Clinical trials (MVOR-1 and MVOR-2) demonstrated Emrosi's superiority over placebo and doxycycline (40mg) in reducing inflammatory lesions and erythema. • Emrosi is the first oral, systemic therapy approved to address both erythema and inflammatory lesions associated with rosacea. • Journey Medical anticipates Emrosi's availability in late Q1 or early Q2 2025, positioning it as a potential best-in-class treatment.

Journey Medical's Emrosi Receives FDA Approval for Rosacea Treatment

• The FDA has approved Journey Medical's Emrosi (minocycline hydrochloride extended-release capsules, 40 mg) for treating inflammatory lesions of rosacea in adults. • Phase 3 clinical trials demonstrated Emrosi's statistically significant superiority over Oracea and placebo in Investigator's Global Assessment and lesion reduction. • Journey Medical anticipates Emrosi will be available in the U.S. by late Q1 or early Q2 2025, aiming to establish it as a new standard of care. • Emrosi was developed in collaboration with Dr. Reddy's Laboratories Ltd and will be commercialized by Journey Medical's dermatology-focused team.
© Copyright 2025. All Rights Reserved by MedPath