Doxycycline
- Generic Name
- Doxycycline
- Brand Names
- Acticlate, Adoxa, Apprilon, Atridox, Doryx, Doxy, Doxycin, Lymepak, Mondoxyne, Monodox, Morgidox, Okebo, Oracea, Periostat, Targadox, Vibramycin
- Drug Type
- Small Molecule
- Chemical Formula
- C22H24N2O8
- CAS Number
- 564-25-0
- Unique Ingredient Identifier
- 334895S862
- Background
Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. It is a second-generation tetracycline that was first discovered in 1967. Second-generation tetracyclines exhibit lesser toxicity than first-generation tetracyclines. Doxycycline is used to treat a wide variety of gram-positive and gram-negative bacterial infections. It is also used to treat acne and malaria.
- Indication
Doxycycline is indicated for the treatment of various infections by gram-positive and gram-negative bacteria, aerobes and anaerobes, as well other types of bacteria, including:
It is also used to treat infections caused by the following gram-negative microorganisms:
- Associated Conditions
- Acinetobacter Infections, Anthrax, Bacterial Infection caused by Enterobacter aerogenes, Bartonellosis, Brucellosis, Campylobacter Infection, Chancroid, Chlamydia Trachomatis Infection, Early Lyme Disease, Granuloma Inguinale, Infection Due to Escherichia Coli, Inhalational Anthrax, Klebsiella Infections, Lymphogranuloma Venereum, Malaria caused by Plasmodium falciparum, Nongonococcal urethritis, Plague caused by Yersinia pestis, Psittacosis, Rectal infection caused by Chlamydia Trachomatis, Relapsing fever caused by Borrelia recurrentis, Respiratory Tract Infection Bacterial, Rickettsial infectious disorders, Severe Acne, Sexually Transmitted Infections (STIs), Shigella Infection, Trachoma inclusion conjunctivitis, Tularemia, Vibrio Cholerae Infection, Acute Intestinal amebiasis, Susceptible Bacterial Infections, Uncomplicated endocervical infection, Uncomplicated urethral infection
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.
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.
PolyPid's D-PLEX100 Poised for Potential 2026 Launch After SHIELD II Trial Update
• PolyPid's SHIELD II Phase 3 trial for D-PLEX100, targeting surgical site infections, is set to conclude enrollment at 800 patients following DSMB recommendation.
• Top-line results from the SHIELD II trial are expected in Q2 2025, with a rolling NDA submission to the FDA planned for Q3 2025.
• D-PLEX100 has Fast Track and Breakthrough Therapy Designation, potentially leading to Priority Review and a possible FDA approval in early 2026.
• PolyPid is also collaborating with ImmunoGenesis to develop novel solid tumor treatments using PLEX technology and a STING agonist.
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.
PolyPid's D-PLEX100 Phase 3 Trial Advances with Positive DSMB Recommendation and $41 Million Financing
• PolyPid's SHIELD II Phase 3 trial for D-PLEX100, aimed at preventing surgical site infections in abdominal colorectal surgeries, will continue enrollment to 800 patients.
• The decision follows a positive recommendation from the Data Safety Monitoring Board (DSMB) based on unblinded efficacy data from the first 430 patients.
• PolyPid secured a private placement financing of up to $41 million, extending its cash runway beyond potential NDA approval into Q3 2025.
• Top-line results from the SHIELD II trial are anticipated in Q2 2025, with a potential New Drug Application (NDA) submission to follow.
Fortress Biotech Highlights FDA Approval of Emrosi and Cosibelimab's Upcoming PDUFA Date
• Fortress Biotech announced FDA approval for Emrosi (minocycline hydrochloride) for treating inflammatory lesions of rosacea in adults, marking their first FDA approval.
• The PDUFA goal date for cosibelimab, an anti-PD-L1 antibody, is set for December 28, 2024, targeting metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC).
• Clinical data presented at the Fall Clinical Dermatology Conference showed Emrosi has higher dermal concentration than oral doxycycline for rosacea treatment.
• Longer-term data from the pivotal trial of cosibelimab in cSCC demonstrated deepening responses over time, with higher objective and complete response rates.
PolyPid's SHIELD II Trial for D-PLEX100 Nears Completion, Interim Analysis Expected Soon
• PolyPid's SHIELD II trial, evaluating D-PLEX100 for surgical site infection prevention in colorectal surgeries, anticipates full enrollment by December 2024.
• An interim analysis of the SHIELD II trial is expected this quarter, potentially leading to early conclusion or continuation based on efficacy results.
• PolyPid reported $9.5 million in cash, sufficient to fund operations into early 2025, with possible access to an additional $24.6 million through financing.
• The company anticipates a strategic partnership for U.S. commercialization of D-PLEX100 and plans to submit a New Drug Application by 2026, pending trial outcomes.
PolyPid's SHIELD II Trial Progresses Amid Q3 Results
• PolyPid reported its Q3 results, highlighting the ongoing progress of the SHIELD II trial, which is evaluating a novel approach to surgical site infection prevention.
• The SHIELD II trial is a significant step forward in addressing the unmet need for effective surgical site infection prevention strategies.
• The company's innovative approach has the potential to improve patient outcomes and reduce healthcare costs associated with surgical site infections.
PolyPid's D-PLEX100 SHIELD II Trial Completes Patient Enrollment for Interim Analysis
• PolyPid has completed enrollment of 430 patients in the SHIELD II Phase 3 trial of D-PLEX100, triggering an unblinded interim analysis.
• The interim analysis outcome, expected later this quarter, could lead to early trial conclusion, sample size re-assessment, or continuation to planned recruitment.
• SHIELD II is expected to complete enrollment of up to 630 patients in December 2024, with top-line results anticipated in the first quarter of 2025.
• D-PLEX100 aims to prevent surgical site infections (SSIs) following abdominal colorectal surgeries, addressing a critical unmet need.
FDA Approves Emrosi (Minocycline) for Rosacea Treatment
• The FDA has approved Emrosi, an oral minocycline capsule, for treating rosacea in adults, offering a new option to manage the pimple-like bumps by reducing inflammation.
• Emrosi's formulation includes immediate and extended-release minocycline, designed for once-daily dosing to maintain steady drug levels and potentially reduce side effects.
• Clinical trials demonstrated Emrosi's effectiveness in improving rosacea symptoms compared to placebo and a standard treatment, with availability expected in late 2024 or early 2025.
• Common side effects include indigestion, and warnings advise against use during later pregnancy and early childhood due to potential tooth staining and bone growth effects.
FDA Approves Journey Medical's Emrosi for Inflammatory Lesions of Rosacea
• The FDA has approved Journey Medical's Emrosi (minocycline hydrochloride) for treating inflammatory lesions of rosacea in adults.
• Phase 3 trials demonstrated Emrosi's superiority over Oracea and placebo in Investigator's Global Assessment treatment success and lesion reduction.
• Emrosi is expected to be available in late Q1 or early Q2 2025, with Journey Medical preparing for a successful launch.
• Rosacea affects over 16 million people in the US, significantly impacting self-esteem and professional 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 Emrosi (Minocycline) for Rosacea Treatment
• The FDA has approved Emrosi (minocycline hydrochloride extended-release capsules 40 mg) for treating rosacea in adults, offering a new therapeutic option.
• Phase 3 trials demonstrated Emrosi's superiority over placebo and Oracea (doxycycline) in improving IGA scores and reducing inflammatory lesions after 16 weeks.
• Developed by Journey Medical in collaboration with Dr. Reddy’s Laboratories, Emrosi is expected to be available in the U.S. market in early 2025.
• Emrosi's narrow spectrum of antibiotic activity may appeal to patients concerned about antibiotic resistance, according to the National Rosacea Society.
FDA Approves Journey Medical's Emrosi™ for Rosacea Treatment
• Journey Medical's Emrosi™ (minocycline hydrochloride extended-release capsules, 40 mg) has received FDA approval for treating inflammatory lesions of rosacea in adults.
• Phase 3 clinical trials demonstrated Emrosi's superiority over Oracea® and placebo in reducing inflammatory lesions and achieving Investigator's Global Assessment treatment success.
• Journey Medical anticipates Emrosi™ will be available in the U.S. market in late Q1 or early Q2 2025, with plans to establish it as a new standard of care.
• Emrosi™ showed great efficacy and tolerability in clinical trials, offering a new treatment option for millions of rosacea patients in the U.S.
PolyPid Gains Momentum with Positive Phase 3 Outlook for D-PLEX100
• PolyPid's stock is gaining traction following a Buy rating from Craig-Hallum, driven by promising Phase 3 data expectations for D-PLEX100 in preventing surgical site infections (SSI).
• The upcoming Phase 3 SHIELD II trial results are anticipated to be a catalyst, potentially unlocking a $1.5 billion market for high-risk surgical patients.
• Despite a net loss reported in Q2 2024, PolyPid completed patient enrollment for the interim analysis of the SHIELD II trial, with top-line results expected in Q1 2025.
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.
FDA Gears Up for Key Decisions on Rosacea, Lung Cancer, AADC Deficiency, and ALL Therapies
• Journey Medical's DFD-29 awaits FDA decision as a potential oral treatment for rosacea, demonstrating superiority over existing treatments in Phase III trials.
• Merus seeks approval for zenocutuzumab, a bispecific antibody targeting NRG1 fusions in NSCLC and PDAC, with promising Phase I/II results showing objective response rates.
• PTC Therapeutics anticipates FDA verdict on Upstaza, a gene therapy for AADC deficiency, already approved in Europe and aimed at addressing the underlying genetic cause.
• Autolus Therapeutics' obe-cel, a CAR T therapy for relapsed/refractory B-cell ALL, awaits FDA decision, supported by Phase II data showing high remission rates and manageable safety.
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